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ABRS Solutions

Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from ABRS Solutions, Medical Research Center, Miami, FL.

We support the drug development and medical device industry with solutions that improve the identification, activation, training, and management of clinical trials and their study sites.

12/31/2022

New is the year, new are the hopes, new are the resolutions, and new are our best wishes for you!

12/24/2022

Happy holidays to you and yours! May the spirit of love and peace be with you throughout the season and into the New Year.

12/09/2022

Why is this important?
* Inadequate clinical study oversight could result in critical GCP inspection findings & delay Health Authority approvals
* ICH E6 5.2.1 "A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor…"
* ICH E6 5.2.2 "The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s)." - NEW
* FDA Guidance, " 'Although sponsors can transfer responsibilities for monitoring to a CRO(s), they retain responsibility for oversight of the work completed by the CRO(s) that assume this responsibility."

Let ABRS equip you with the proper tools to ensure watchful and responsible Study Oversight of your Clinical Trials!

11/24/2022

We are feeling grateful this Thanksgiving for clinical research.
Happy Thanksgiving from ABRS.

11/18/2022

Our ABRS team participated as guest speakers in the talk "Three Significant Challenges When Positioning a Research Center," hosted by the Association of Research Centers of Colombia (ACIC). Our goal with this participation is to continue sharing our experience and helping to strengthen Clinical Research in LATAM.

11/04/2022

Today, ABRS impacts 80 cities in 11 countries in North, Central & South America, Europe, and Asia Pacific. Our elite network of Ambassadors are helping optimize clinical development by scaling trial resources, accelerating timelines and deliverables, and maximizing the efficiency of life-saving clinical trials.

Join us, and let ABRS help you bring clinical research to different parts of the world!

10/21/2022

Top priorities for global clinical sites: budgets, communication, and technology

According to recent surveys, the trending issues that matter most to global clinical sites are:
• Providing open communication regarding budgets and negotiations
• Timely and expedited payments
• Offering patients the opportunity to take advantage of home visits
• Offering patients reimbursement and travel assistance
• Cross-platform integration
• Faster and more efficient communication between Sponsors, CROs, and Research Centers

At ABRS, we understand why these issues matter and continue to work towards ensuring clinical research sites are heard when it comes to these priorities.

10/06/2022

Diversity Plans to Improve the Enrollment of Underrepresented Participants in Clinical Trials

In April 2022, the FDA made available a 12-page draft guidance document that provides information representing the FDA's suggestions and recommendations for sponsors seeking to improve the enrollment of participants from underrepresented racial and ethnic populations into clinical trials. While the industry has made significant strides on this issue, there is still a long way to go. At ABRS, we offer expertise to support and guide Sponsors to ensure diversified trials that better serve our communities.

ABRS

09/29/2022

Every year, over 17 million people die from heart disease. Fortunately, the leading causes of cardiovascular disease are modifiable factors, which include lack of exercise, smoking, and a poor diet.

So how should you observe World Heart Day?

* Designate the day for a checkup. You may even be able to find a World Heart Day event near you that's offering health check services. It doesn't get much easier than that! 
* Get your heart rate up with fitness events! Maintaining a healthy weight and low Body Mass Index (BMI) can help decrease your chances of developing heart disease. Whether you attend a gym or fitness class or prefer to get involved at a World Heart Day event try to make being active a priority. 
* Schedule life-changing seminars. Most cardiac emergencies occur near someone who could potentially help so setting up a CPR class and learning how to resuscitate a person could save lives. Cooking demonstrations, health lectures, and fitness lessons are great events to plan for World Heart Day.

This year's World Heart Day theme is "Use Your Heart for Every Heart." So let's do just that by spreading ways we can help prevent CVD.

Happy World Heart Day from ABRS!

09/22/2022

To help assure continued safety and effectiveness, the FDA may require a Post-Approval Study (PAS). It's important to remember that a Sponsor's failure to comply with any post-approval requirements may be grounds for the FDA to withdraw approval. So, because of this, we need to remind ourselves that Post-Approval Studies are conditions for device approval and must be handled with the same attention and care as any other clinical trial.

At ABRS, we understand the importance of PAS trials and we love reminding folks how important they are.

To learn more about PAS trails, visit
https://www.fda.gov/medical-devices/postmarket-requireme
nts-devices/post-approval-studies-program

ABRS

09/09/2022

Our ABRS Ambassadors bridge the gap between adequate and exceptional

Imagine having a Functional Service Provider (FSP) who understands your needs and is fully engaged in the assignment at hand. ABRS delivers that remarkable experience with our Ambassador Program, which equips the FSPs with the tools to communicate and deliver an exceptional service effectively.
ABRS has opportunities for dynamic and enthusiastic senior-level research professionals to become Ambassadors in North America, LATAM, and Spain. Let's connect! Contact us at info@ABRSolution.com or latam@abrsolution.com to learn more.

09/02/2022

Clinical Trials save lives
Inmaculada was diagnosed with metastatic lung cancer, for which her doctor gave her four months to live. After this hard news, she decided to participate in a clinical trial that targeted her tumor type. After four YEARS, Inmaculada is still fighting, not only to beat cancer but to inspire others to participate in clinical research.

At the ABRS, we believe we are helping give hope to people with various diseases. We invite you to visit the NHLBI website: https://www.nhlbi.nih.gov/research/clinical-trials

An entity that provides leads to clinical trials for patients with conditions or disorders related to the heart, lungs, blood, or sleep. Find studies for different diseases and conditions and see if you or a loved one is eligible.
# Support clinical trials

08/12/2022

As we know, there are traditional clinical trials in which patients voluntarily come to a center where they are assessed and enrolled when suitable for the study.

Decentralized Clinical Trials (DCT) are conducted remotely rather than at a central facility, and patients remain at home for most of the trial. In this case, interactions with centers occur via software, phone applications, and connected devices.

Regardless of the approach, the involvement of patients in the clinical trial process and ensuring their needs are the study's foremost priorities.

Based on this, how do you visualize future directions for clinical trials?

08/05/2022

At ABRS, our Subject Matter Experts specialize in current legislation, guidelines, and other regulatory information to stay well versed regarding today’s complex and changing global regulatory landscape, thus delivering quality regulatory services and submissions efficiently. Our experience with the international regulatory authorities allows us to deliver strategic and operational support to expedite clinical trials and device development programs.

07/24/2022

The Tufts Center for the Study of Drug Development (CSDD) estimates that the total capitalized cost for an approved new compound is $2.6 billion.
As we can see, reducing costs is critical to meeting patient needs and bringing drugs into the market.

07/22/2022

The Tufts Center for the Study of Drug Development (CSDD) estimates that the total capitalized cost for an approved new compound is $2.6 billion.

Reducing this cost is critical to meeting patient needs and bringing drugs to market.

05/30/2022

Today we want to express our gratitude and honor the veterans that have fought for America’s freedom. ABRS is proud to be an American company and proud to celebrate Memorial Day. 🇺🇸

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Miami, FL

Website

http://abrsolution.com/

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