Category: Health & Medicine

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Health & Medicine U.S

Berkeley Immune Support Formula As The Most Potent Immunity Booster Health Supplement

Los Angeles, California (December 08, 2023) – Berkeley Immune Support Formula is a health supplement that has completely changed the nutritional sciences industry ever since it has been launched. The University of California at Berkeley was exploring the various properties of DIM or Diindolylmethane, a naturally occurring chemical compound that is found in abundance in Brassica vegetables, such as broccoli, kale, cabbage, cauliflower and brussels sprouts.

While doing their research, the team at the University of California at Berkeley discovered that the Diindolylmethane (DIM) is a powerful activator of the body’s immune response system. In fact, the DIM vitamin is the most effective and powerful booster of the body’s natural immune system known at present within the sphere of nutritional science. The unique molecular biology of DIM together with its ability to enhance the whole immune response system makes it a powerful health supplement in its own right.

Ever since the news about the DIM was published for the first time, scientists at the Berkeley have been trying to come up with health supplements that make the best use of this naturally occurring compound. University of California at Berkeley then co-founded Berkeley BioSciences, Inc. to further their goals on research and development of nutritional products and innovative therapeutics that make use of this compound. The Berkeley Immune Support Formula was the first supplement product that was created by Berkeley BioSciences.

This unique DIM supplement was made for enhancing the functioning of the immune system. It was also meant to help raise the funds needed to facilitate further nature-based biomedical research. This nutritional immune system boosting supplement combines the goodness of multiple nutrients to ensure maximum effectiveness. The ingredients include Diindolylmethane (DIM), Selenium, Sulforaphane, Zinc, Lycopene, Citrus Bioflavonoids, Zeaxanthin, Lutein and Vitamin D3.

The Berkeley Formula is currently regarded as the best and most reliable bioavailable DIM supplement in the market that can effectively boost the immune system to prevent health issues. For this reason, the Diindolylmethane supplement is recommended by doctors and professional nutritional scientists actively carrying out research on this compound and also looking into other types of important nutrients that are found in this formulation. Immunologists across the globe also recommend using this formula as it can boost the functioning of the immune system significantly. The DIM pills are also used by sports nutritionists when they are looking to help athletes recover quickly from their injuries and get back in shape. DIM also combines phytonutrients that are naturally present in broccoli, tomatoes and spinach.

About Berkeley Immune Support Formula

Berkeley Immune Support Formula is a health supplement that brings the goodness of DIM to boost the health and well-being of the users.  

To know more about Berkeley Immune Support Formula, visit https://bit.ly/diindolylmethanedimsupplement

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Family & Parenting Health & Medicine Lifestyle Living U.S

Hannah Agoston M.S. CCC-SLP: A Beacon of Innovation in Speech-Language Pathology and Orofacial Myofunctional Therapy

Akron, Ohio – November 16th, 2023 – Encouraging Words, LLC proudly celebrates its founder, Hannah Agoston M.S. CCC-SLP, a vanguard in the field of speech-language pathology and orofacial myofunctional therapy. With a career spanning over two decades, Hannah has distinguished herself as a therapist, educator, and advocate, bringing a transformative approach to therapy and patient care.

As a respected graduate clinician supervisor for Kent State University and a former Therapy Director at McGuire Orthodontics and Facial Orthopedics, Hannah’s expertise and leadership have left an indelible mark on the community and profession. Her personal journey, intertwined with her roles as a wife and mother to three amazing children, underscores her dedication to nurturing growth and development both at home and in her professional endeavors.

Hannah’s innovative spirit is most evident in her establishment of Encouraging Words, LLC, where she has implemented a comprehensive, holistic approach to therapy. “We believe in considering the entire human and challenging the status quo in our field,” states Hannah. This philosophy is evident in the center’s comprehensive assessments, bespoke 1:1 therapy sessions, and its pioneering MyoKit, designed to simplify and enhance therapeutic practice.

Her contributions extend beyond clinical practice, with a rich history of professional training, presentations, and volunteer work. 

As a passionate supporter of all modes of communication, from American Sign Language (ASL) to auditory-oral methods, Hannah’s practice at Encouraging Words, LLC is not just a profession but a continuation of her life’s mission. Her profound commitment is rooted in her personal journey, growing up close to a cousin who is deaf and having multiple family members who are deaf or hard of hearing. Her dedication to this community was profoundly shaped by over a decade of exclusive work with various schools and DHH programs, one being the Pennsylvania School for the Deaf in Philadelphia, where she was deeply ingrained in Deaf culture.

Hannah is a passionate Breathe Ambassador, advocating for awareness and treatment of orofacial myofunctional disorders. Her in-service training, seminars, and workshops cover a spectrum of topics, from sleep apnea to tongue-tie, underscoring her commitment to advancing knowledge and practice in her field.

Hannah’s volunteerism and community engagement are hallmarks of her character. From providing annual hearing screenings for the Spring Garden Waldorf School to her active participation in cochlear implant task forces, her altruistic spirit shines through. 

As a former district representative with the Metro Speech-Language Network & Symposium, she has been a driving force in promoting excellence and collaboration among her peers.

Encouraging Words, LLC is a testament to Hannah Agoston’s vision of integrated, patient-centered care. It stands as a beacon of innovation, reflecting her unwavering commitment to enhancing the lives of those with communication and orofacial challenges. Her legacy is one of compassion, expertise, and relentless pursuit of excellence.

For more information about Hannah Agoston’s work or to explore the services offered at Encouraging Words, LLC, visit EncouragingWordsTherapy.com.

About Encouraging Words, LLC: Encouraging Words, LLC is a premier center for speech-language pathology and orofacial myofunctional therapy in Akron, Ohio. Founded by Hannah Agoston M.S. CCC-SLP, the center is dedicated to providing innovative, comprehensive care, ensuring each patient achieves optimal communication and orofacial function.

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Health & Medicine U.S

Berkeley BioSciences, Inc. Unravels the Science behind the Optimal Immune Boosting Capacity of its DIM supplement, Berkeley Immune Support Formula

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Berkeley BioSciences, Inc., a leading dietary supplement company, has just shared information about its diindolylmethane (DIM) supplement, Berkeley Immune Support Formula, and how it has been engineered to optimize immune system support for users. Its makers have attempted to disclose the science behind the DIM supplement, in order to satisfy the curiosity of users as well as to dispel misconceptions about it.

According to the team at Berkeley BioSciences, Inc. Berkeley Immune Support Formula is no ordinary DIM supplement. The makers have gone above and beyond to ensure that their product provides more than just bioavailable DIM. The product has been formulated to provide optimal support for the immune system, helping users to maintain a healthy immune response and overall well-being. The goal in the development of this product has been to pay meticulous attention to the nutrikinetics of the nutrients provided, ensuring that they work synergistically to maximize their combined effect on the immune system and other organ systems in the body.

“We have come up with one of the few dietary supplements in the industry that has been engineered by senior nutritional scientists and molecular biologists with clinical efficacy being our number one priority,” said a representative from Berkeley BioSciences, Inc, “Our diindolylmethane supplement has been engineered to achieve this maximum combined impact, with the dosages, bio availabilities, and kinetics of absorption of each nutrient meticulously optimized.”

With a focus on clinical efficacy and customer satisfaction, Berkeley BioSciences, Inc. is dedicated to providing products that support optimal health and well-being. In addition to DIM, the Berkeley Immune Support Formula also includes other immune-supporting nutrients such as vitamin C, zinc, and selenium. These nutrients have been carefully selected and formulated to work together synergistically, enhancing the overall efficacy of the product.

C-max, which stands for maximum concentration, refers to the highest concentration of a particular nutrient within the bloodstream after ingestion. When two or more nutrients are known to work well together to achieve a desired biological result, the overlapping of their C-max curves helps to deliver maximum clinical efficacy to end consumers.

“We understand that the immune system is a complex network of cells, tissues, and organs that work together to defend the body against harmful invaders,” said the representative. “That’s why we’ve formulated our Berkeley Immune Support Formula to provide comprehensive support for the immune system, helping users to maintain optimal health and well-being.”

The Berkeley Immune Support Formula is available for purchase on the Berkeley BioSciences, Inc. website and is backed by a 100% satisfaction guarantee. Users can feel confident in their purchase, knowing that they are getting a high-quality, scientifically formulated supplement DIM that has been engineered for maximum clinical efficacy.

About Berkeley Immune Support Formula

The Berkeley Immune Support Formula is the result of years of research and development, with a focus on maximizing the benefits of each nutrient included in the formula. It has been brought out by Berkeley BioSciences, Inc., a top dietary supplement company that specializes in the development and production of high-quality, scientifically formulated supplements.

For further information on Berkeley Immune Support Formula, visit https://www.berkeleyformula.com/

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Health & Medicine

Madavi Aesthetics Redefines Beauty with Top-tier PRP Hair Treatment and Microneedling Services in Beverly Hills, CA

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Beverly Hills, CA (October 09, 2023) – Madavi Aesthetics, a renowned name in the world of beauty and wellness, is proud to offer superlative PRP Hair Treatment and Microneedling services in the heart of Beverly Hills, California. With a commitment to excellence and a dedication to delivering guaranteed results, the center stands out as a trusted destination for those seeking transformative beauty treatments.

PRP and PRF are cutting-edge regenerative treatments that utilize the patient’s own blood to stimulate healing and tissue regeneration. PRP involves the concentration of platelets from a small blood sample, which is then re-injected or applied to the treatment area. PRF, an advanced version of prp therapy Beverly Hills, incubates longer to form a richer fibrin matrix, enhancing growth factors and promoting a superior healing response.

Both prp hair treatment services Beverly Hills CA and prf therapy Beverly Hills can be seamlessly combined with other treatments, including the popular “Vampire Facial” Microneedling and Morpheus8. These treatments are not only effective for hair restoration but also for rejuvenating the skin, reducing fine lines, and achieving a radiant complexion. Madavi Aesthetics offers these groundbreaking PRP and prf hair treatment services Beverly Hills CA at competitive pricing.

Microneedling, also known as collagen induction therapy, is a cosmetic procedure that stimulates collagen and elastin production by creating small punctures in the skin. This non-invasive treatment can address a variety of concerns, including acne scars, fine lines, wrinkles, uneven skin tone, and large pores. Madavi Aesthetics employs the Rejuva Pen for this procedure, ensuring maximum effectiveness and minimal downtime, typically ranging from 2 to 5 days.

“With a recommended minimum of three sessions spaced four weeks apart, clients can achieve optimal results.”, says a medical staff associated with the center, “To enhance the results and accelerate healing, Microneedling can be combined with PRP, a painless process aided by the application of numbing cream prior to treatment.”

Microneedling is a versatile treatment suitable for various areas of the body, including the face, neck, décolletage, and hands. Whether targeting acne scars or signs of aging, microneedling with prp Beverly Hills can revitalize and rejuvenate the skin. The procedure is virtually painless, thanks to the application of numbing cream before treatment.

Madavi Aesthetics offers Microneedling treatments at a competitive pricing. Further, new clients can enjoy a 15% discount on their first treatment, making it an ideal time to experience the rejuvenating effects of Microneedling at this center.

For those seeking the latest advancements in regenerative beauty treatments and skin rejuvenation, Madavi Aesthetics is the ultimate destination. With a commitment to delivering guaranteed results and an emphasis on affordable pricing, this center has established itself as a leading provider of transformative beauty services in Beverly Hills, CA. Its team of experienced professionals is dedicated to helping clients achieve their beauty goals with innovative and effective treatments.

About Madavi Aesthetics

Madavi Aesthetics is a trusted beauty and wellness center located in Beverly Hills, CA. With a focus on regenerative beauty treatments such as prf injections Beverly Hills and skin rejuvenation, it delivers exceptional results at competitive prices.

 

For more information or to book an appointment, visit https://madaviaesthetics.com/services/prpprf

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Health & Medicine

Gaining Ground Emerges as the Most Popular Clinical Mental Health Counseling Center in Rochester in Online Poll

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Rochester, NY (October 07, 2023) – Gaining Ground, a leading mental health counseling center in Rochester, New York, has received overwhelming support from its clients, earning the prestigious title of “Most Popular Clinical Mental Health Counseling Center in Rochester” in an online poll. With a dedicated team of professionals and a commitment to personalized care, the mental health Rochester center has established itself as a trusted resource for individuals and families seeking mental health support.

Gaining Ground offers a wide range of evidence-based services to address diverse mental health needs. Its individual therapy sessions are designed to help clients explore and manage mental health symptoms and root causes. The center also provides diagnostic testing to accurately identify mental health conditions, ensuring a tailored treatment approach.

For couples facing relationship challenges, Gaining Ground offers couples counseling Rochester and therapy, focusing on conflict resolution, communication improvement, and intimacy enhancement. Furthermore, its family therapy Rochester services provide families with a platform to address conflicts and communication breakdowns, fostering empathy and understanding among family members.

Mental health therapy is essential for individuals facing a variety of challenges, from stress and anxiety to depression and emotional struggles. Seeking help is a courageous step towards healing and personal growth. Gaining Ground recognizes the significance of this decision and offers a compassionate, non-judgmental environment where clients can explore their thoughts and experiences.

Gaining Ground stands out in the field of mental counseling Rochester and mental health therapy in several ways. Its counselors believe in tailoring therapy to meet each client’s unique needs and goals. Thus, there is no one-size-fits-all approach to mental health, and the center embraces the philosophy of Individualized Treatment Plans. Their holistic approach to mental health therapy extends beyond traditional counseling. They recognize the importance of addressing mental health from various angles and offer services that cater to mind, body, and spirit. These services include mindfulness and relaxation techniques, stress management strategies, and more.

The center utilizes evidence-based therapies, drawing from the latest research in the field of mental health to provide the most effective and up-to-date treatments. At Gaining Ground, the counselors always strive to create a safe and welcoming space where clients can openly explore their thoughts and emotions without fear of judgment.

Here, mental health counseling programs Rochester involve collaboration between therapists and clients, ensuring that the goals and preferences of clients are at the forefront of treatment. The journey to mental health is not always straightforward, and Gaining Ground offers continuous support and guidance to clients throughout their therapeutic journey. The center is deeply committed to breaking the stigma surrounding mental health. Its experts believe that everyone deserves the opportunity to lead a fulfilling and mentally healthy life. Through their exceptional services, they aim to empower individuals to take charge of their mental well-being.

About Gaining Ground

Gaining Ground is a leading clinical mental counseling Rochester center located in NY. It is committed to helping individuals prioritize their mental well-being with a range of mental health therapy services, including individual and couples counseling, group therapy, and holistic approaches to mental health.

For more information or any enquiry, visit https://www.ggmhcny.com/rochester-mental-health/

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Business Health & Medicine Professional Services

Denti e Sorrisi: Pioneering Affordable Dental Tourism with High-Quality Services in Albania

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Tirana, Albania – Dr. Armand Alushi and Dr. Luela Mamaj, the proud owners of the dental clinic and building, Biodent Denti e Sorrisi in Tirana, are thrilled to share their journey of establishing a dental clinic that has become a beacon for dental tourism in Albania, especially for Italian and European citizens. With a focus on providing high-quality dental treatments and products that stand the test of time, the clinic has successfully treated approximately 12,000 patients over the past 15 years.

Choosing the right dental clinic can be a daunting task, considering various factors like the structure of the dental clinic and the cost of treatments. Denti e Sorrisi has emerged as a reliable choice by ensuring that the right prices are offered, enabling people from all walks of life to access top-notch dental treatments.

The clinic has steadily grown its patient base, starting with 3 monthly patients and now catering to around 40 monthly patients, primarily through word-of-mouth recommendations. Since embracing the web in 2019, the clinic has seen a surge in patients, hosting up to 80 per month, with 70% of them seeking dental implantology and dental aesthetics services.

Denti e Sorrisi offers a plethora of services, including but not limited to, dental implants, osseointegrated implants, dental prostheses, oral surgery, aesthetic dentistry, oral hygiene, conservative dentistry, teeth whitening, dental veneers, dental emergency room services, and treatments for bacterial infections. The clinic also specializes in various orthodontic treatments, such as fixed, mobile, and invisible orthodontics, ensuring comprehensive dental aesthetics services.

Dr. Alushi and Dr. Mamaj express their joy, stating, “We are happy to have carried out dental tourism in Albania all these years with our profession of dentists in Tirana. Our experience and the trust placed in us by our patients have made us significant in this sector.”

The clinic’s success is not only attributed to the expertise of its founders but also to its commitment to providing affordable yet high-quality dental services. The clinic prides itself on being a “cheap dentist good honest low-cost dental clinic” without compromising the quality of its services and products.

Denti e Sorrisi has not only provided impeccable dental services but also contributed to promoting dental tourism in Albania, allowing individuals to explore the beautiful country while addressing their dental needs. The clinic stands as a testament to the potential of combining quality healthcare services with tourism, providing a holistic experience to its international clientele.

For more information or to explore the range of services offered, visit Denti e Sorrisi’s official website.

About Denti e Sorrisi:

Denti e Sorrisi, located in Tirana, Albania, is a premier dental clinic owned by Dr. Armand Alushi and Dr. Luela Mamaj. With 15 years of experience and serving approximately 12,000 patients, the clinic has become a pivotal establishment in promoting dental tourism in Albania by offering a wide array of high-quality dental services at affordable prices.

Press Contact:

Denti e Sorrisi

Tel: 355684575475

Email: dentiesorrisi@gmail.com

Address: 5 Ilo Mitke Qafzezi Street, Tirana 1019, Albania

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Health & Medicine

American Institute of Health Science and Technology Provides the Best Training for Aspiring Doctors

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The American Institute of Health Science and Technology is a medical school in Virginia that takes a progressive approach while training prospective doctors and medical experts so that they may treat their patients with a high level of efficiency. The medical training center adopts a diverse and efficient method of teaching medical students the ways of modern medicine so that they may attain success as practicing medical professionals. Health science is meant to preserve the health and well being of all people so that they can stay fit and have a better quality of life. At the American Institute of Health Science and Technology, students learn about the best ways in which they can diagnose and cure diseases and serve humanity in the best possible manner.

The Healthcare Administration Program as provided by American Institute of Health Science and Technology has been designed to make sure that all the students studying medical science at the institution are able to achieve success in their ventures and that they are able to accomplish their academic goals. The institution also guides young doctors in a way that they are able to use their skills to pursue a medical career direction that they feel is best for them. American Institute of Health Science and Technology is thoroughly committed to provide high quality education to students from the country and other parts of the world, while making sure that the prices are affordable.

One of the most notable programs offered at the American Institute of Health Science and Technology is its Dental Assistant Program. It is one of the best programs for anyone looking to pursue a career in the sphere of dentistry. The comprehensive program has been designed to help potential dental assistants to cultivate the skills and the knowledge that they need to have to resolve the dental problems that the patients may have. The program can help students to develop a strong understanding and foundation of dental assisting. It encompasses various subject matters central to dental healthcare, such as dental anatomy, dental radiography, infection control, dental materials, oral health education and chairside assisting techniques. The program combines the best of practical training and theory to make sure that the students are able to cultivate the necessary skills that they must have for providing top notch oral healthcare. 

By signing up for one of the medical assistant programs offered at the American Institute of Health Science and Technology, students can enhance their chances of success in the dynamic medical industry.

About American Institute of Health Science & Technology:

The American Institute of Health Science and Technology is one of the leading centers of medical training in the USA, offering a stellar infrastructure to students so that they can learn all about medical science. 

To know more about American Institute of Health Science and Technology, visit https://aihstusa.com/

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Business Commodity Market Health & Medicine Human Resources Lifestyle

Elite Benefits Group offers affordable healthcare to all

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At Elite Benefits Group, Sierra Gilmore assists individuals with gaining access to the health insurance premiums they deserve. She is a certified marketplace insurance expert. This simply means she has knowledge to navigate the marketplace for you and utilized the Affordable Care Act to ensure you are not overpaying for your health insurance. Many people do not know they qualify for free or super low budget premiums. Sierra knows and will ensure you get the health insurance you deserve. The affordable care act is income based. Therefore your premium is always affordable for you and your financial situation. 

Many people qualify for a subsidency from the government based on their annual income. She helps you access that information. Navigating the marketplace alone can be overwhelming but having an expert makes the process easier and most likely will save you money. 

Not only do she assist individuals but she also assist business such as daycares, home health care agencies and many more set up insurance plans for their employees. Many business say that having Sierra as their personal insurance agent has increased their retention rates. She give employers traditional and non traditional options to ensure they are providing their employees with benefits. 

Elite Benefit Group, a leading and reputable insurance brokerage company based in the US, assists numerous organizations and individuals in locating cost-efficient insurance coverage.

Given the rising cost of healthcare, affordable healthcare has long been a hot topic in the media and public discourse. In addition to assisting low-income families, self-employed individuals, daycare workers, and individuals in navigating the complex world of health insurance, Elite Benefits Group specializes in assisting individuals and businesses find affordable healthcare insurance by comparing plans and prices to find a plan that best suits their requirements and financial situation.

At Elite Benefits Group, a wide range of clients, from small businesses to large corporations and individuals, benefit from their diverse insurance services, which include health, life, and disability coverage, as well as other insurance options. The company is committed to offering personalized service, working closely with each client to identify their distinct needs and objectives, and crafting tailored insurance solutions that precisely match those requirements. The collaborative approach ensures that each client’s unique needs and objectives are fully comprehended, leading to the development of customized insurance solutions.

Angela Knight of House Of Pies, a client said “Being a small business trying to offer extensive benefits to your employees can be overwhelming and expensive. Elite Benefits Group made this task affordable, and understandable and gave our employees great coverage at a low cost to the company. I would and have recommended Elite Benefits Group to everyone!” 

Elite Benefits Group provides consulting services for employee benefits and human resources in addition to insurance brokerage services. Their services involve aiding businesses in creating and implementing employee benefits packages that not only attract and retain high-caliber talent but also ensure compliance with regulatory requirements. Elite Benefits Group understands the challenges of rising healthcare costs and the importance of having access to affordable healthcare. One way Elite Benefits Group helps its clients find affordable healthcare is by comparing plans from different insurance carriers. They can help clients understand the differences between plans, such as deductibles, copayments, and out-of-pocket maximums, and how those differences can affect the overall cost of the plan.

Elite Benefits Group also assists clients to navigate government programs like Medicaid and Medicare, as well as other options for low-cost or free healthcare. 

About: 

Elite Benefits Group is a company that specializes in providing insurance brokerage and consulting services to businesses and individuals. The company is based in the United States and has been in operation for over a decade and hope to reach anyone looking for affordable healthcare because it’s affordable to everyone. 

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Business Health & Medicine Professional Services Public Affairs U.S

The Sosa Insurance Group Is Looking for Medicare Insurance Brokers To Join Their Brokarage Firm In New Jersey

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West Orange, NJ — The Sosa Insurance Group, a trusted Medicare Health Plan Insurance Agency, is looking for new team members to help serve their growing customer base in New Jersey. With a study from the Social Security Administration showing that 13,000 individuals turn 65 every day, this demographic puts Medicare Insurance Health Plans in high demand.

George Sosa, the co-founder of The Sosa Insurance Group, said, “There are not enough insurance brokers in the field to inform and educate and, most importantly, find the right health plan to fit those Medicare-eligible individuals’ needs and affordability.”

The Sosa Insurance Group seeks a self-starter who would like to work as an independent contractor. As a Licensed Insurance Broker of The Sosa Insurance Group, the chosen individual will spend their time informing and educating the Medicare-eligible consumer, assisting the consumer in selecting the appropriate plan for them, and following up with the client to make sure that the application process goes smoothly from start to finish.

This position offers flexible hours and can be full-time or part-time, depending on availability. The ideal candidate is an individual with an entrepreneurial spirit, inherent self-discipline, good time management, a willingness to learn, and an aptitude for sales, and is comfortable working with computers and adapting to changes. Successful agents also have energetic and engaging personalities, excellent communication skills and empathy for others, a genuine passion for helping others, and the ability to overcome sales objections and close leads over the phone.

As an independent contractor, the chosen individual will have the freedom to achieve the level of success they deserve while they build a solid business that will give them an opportunity to receive Lifetime Residual Income, as long as the client is on their book of business. Compensation and benefits include uncapped commission potential, compensation based on a per-client basis, and lifetime residual income from clients assisted in the previous year(s).

The Sosa Insurance Group is unique in its training offerings, providing local support and training remotely, face-to-face, and in the field. Special preference is given to individuals with a health/life license in NJ.

For more information about the position, please visit our website at https://thesosainsurancegroup.com/.

About The Sosa Insurance Group  

The Sosa Insurance Group is proud to offer the West Orange, NJ community top-notch Medicare and Financial Service Plans. Founded in 2014 by George Sosa, we specialize in Medicare Supplement, Medigap, Medicare Advantage, Medicare and Medicaid, Stand-Alone Part D Prescription, Dental, Final Expense, Individual, Long-Term Care Plans, and Financial Service Plans.

George Sosa has been in the Sales and Marketing field for 30 years, holding a B.A. from Rutgers University and having completed numerous continuing education courses and seminars in sales, marketing. Fluent in Spanish, he is a devoted father of three children who founded the company to help retirees and provide flexibility and stable income to brokers. With a passion to inform and educate retirees on the importance of the right Medicare Health Plan, we have become a well-respected presence in West Orange.

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Health & Medicine Science Technology U.K U.S

FDA Releases Draft Guidance for Decentralised Clinical Trials; Adoption of DCT is Expected to Increase

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The US Food and Drug Administration (FDA) has reportedly released a draft guidance detailing its recommendations on performing decentralised clinical trials (DCTs) for drugs, biological products and medical devices.

With the draft, FDA is committed to providing trial sponsors, researchers, and other stakeholders with guidance on how to accelerate DCT adoption to facilitate drug development, reported European Pharmaceutical Review.

FDA’s New Draft Guidance

The newly issued draft guidance is developed on the recommendations the agency detailed in 2020. With the earlier guidance, FDA aimed to help study teams facilitate trial decentralisation in response to the disruptions (e.g. travel restrictions, site closure, quarantines) and public health emergencies caused by the COVID-19 pandemic. 

“The FDA has long considered the benefits of decentralised clinical trials. Advancements in digital health technologies and the COVID-19 pandemic – when in-person visits were limited or unavailable for many trial participants – have accelerated the broader adoption of these activities,” explained FDA Commissioner Dr. Robert Califf.

This new draft offers recommendations related to the FDA’s conditions for investigations of medicinal products when applied to decentralised studies and meets the requirement outlined in section 3606(a)(1), FDA Omnibus Reform Act (FDORA).

FDA released the guidance a few months after the EU regulators demonstrated their recommendations on DCT to help protect the rights and well-being of the trial participants.

In the draft guidance, FDA provides stakeholders with recommendations on DCT design, conducting remote clinical trial visits and clinical trial-related activities, the adoption of digital health technologies (DHT) as enablers of clinical research, the responsibilities of the involved stakeholders, and how investigational medicine should be administered.

Breaking Down the Recommendations

Providing a framework for DCT design, FDA stresses the importance of having a physical location while conducting DCTs to ensure easy access to participant records and investigators’ care.

The trial protocol should clearly define when a tele-health checkup is required and when a patient needs an in-person visit.

FDA urges investigators to confirm participant identity during each remote visit.

According to the agency, the protocols for using DHTs in a virtual trial to gather data for trial endpoints should be compatible with the draft guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigation”.

Additionally, in the newly released draft guidance, the FDA has urged sponsors to strive for enhancing participant diversity and inclusiveness in clinical trials. 

FDA stresses the importance of engaging local healthcare providers (HCPs” in trial activities to build trust with at-risk participants, thus improving the inclusion of diverse populations. 

While DCTs and hybrid models can encourage a much higher enrollment rate, FDA suggests investigators recruit only as many participants as they can efficiently manage to provide enough supervision of trial-related activities. 

According to the agency, while taking remote consent from the trial participants, they should be informed about whom to contact in case they face any health issues during the trial period and who can access their personal health information (PHI) acquired during the DCT.

FDA underscores leveraging central IRB in decentralised trials as a key to facilitating the review of the protocol, the informed consent documents, and other pertinent trial data.

In addition, investigational products (IP) should be administered to the participants only under the in-person supervision of the investigator or the supervision of a sub-investigator answerable to the investigator.

It’s recommended for sponsors to take into account the type of an investigational device, its prospective application, and the associated risks to determine its use cases efficiently.

IPs can be directly delivered to the participants’ location and the trial protocol should clearly define the methods of preserving the integrity and stability of the IP.

FDA recommends the use of a centralised distribution system to facilitate the delivery of IP to trial participants.

The sponsor is responsible for thoroughly monitoring the DCT processes while ensuring the trial is being conducted per the general investigational protocols and considerations included in the IND or IDE applications. 

The implemented safety monitoring plan in a trial should be devised considering the decentralised nature of the investigation. It should ensure any adverse events are detected early, correctly captured, and efficiently addressed.

FDA suggests sponsors implement high-end DCT software that can help manage electronic case report forms (eCRFs) and electronic informed consent (eConsent), schedule trial activities, sync data input in DHTs, and more. 

High-end DCT platforms such as ObvioHealth can efficiently address the issues of data inaccuracy and the interoperability essential to produce robust trial outcomes and endpoints.

Wrapping Up

Decentralised and hybrid study models are considered the way forward to decrease the patient burden. Offering participants the support and flexibility they need, DCTs also help improve data quality. 

The result: augmented trial result and accelerated drug development

“As we seek to improve our evidence generation system, decentralised clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility,” commented FDA Commissioner.