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Functional Service Provider (FSP)

FSP: The Access Point to Better Clinical Data Management

At its core, the success of any clinical trial rests on clean, conclusive data. This creates challenges. Throughout a trial, the data must be properly aggregated, scrubbed, analyzed, acted on—and all those steps must be recorded, to assure regulatory authorities of their accuracy. As the industry continues to evolve, new solutions to these challenges have...

Clinical Research: Phase 1 - Phase 4

IVDR Survival Guide Part 2: Preparing for the NB Bottleneck

The In Vitro Diagnostic Regulation (IVDR) has fundamentally changed how in vitro diagnostics (IVD) are regulated in the EU. As a result, scrutiny for review and documentation has increased substantially, including a dramatic increase in required reviews by notified bodies (NB). For IVD companies, the challenge of adapting to a significant set of regulatory updates...

Clinical Research: Phase 1 - Phase 4

IVDR Survival Guide Part 1: A Deep Dive into Classification, Clinical Evidence, and Performance Requirements

The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition plan went into effect. While some of the dates have been extended1 to allow for...

Clinical Research: Phase 1 - Phase 4

Pursuing the Promise of Gene Therapy: Pathways to Successful Clinical Trials

The promise of gene therapy is to provide transformative treatments that meaningfully improve quality of life for patients, many of whom are currently living with debilitating diseases. To bring these treatments to market, sponsors are tasked with conducting clinical trials that generate robust evidence with appropriate safety oversight. In addition, gene therapy trials are faced...

Clinical Research: Phase 1 - Phase 4

Maximizing Oncology Study Outcomes: Overcoming Enrollment Challenges in a Phase 2 Prostate Cancer Clinical Trial

Prostate cancer (PC) is one of the most commonly diagnosed cancers overall and the most frequently diagnosed cancer in men. The 2018 global estimate of new PC cases exceeded 1.2 million, and more than 350,000 men died from the disease worldwide.1 Over the last decade the emergence of new treatments, combined with better use of...

Clinical Research: Phase 1 - Phase 4

How to Establish Clinical Utility of Molecular Diagnostics for Precision Medicine: 5 Tips on RCT Conduct

Molecular diagnostics can provide a more precise and scientifically sound basis for the practice of medicine. However, barriers to their adoption may increase the risk for developers and delay the practice of precision medicine. With the recent evolution of regulations governing investigational diagnostics, it has become vitally important for diagnostics developers to understand how to...

Clinical Research: Phase 1 - Phase 4

How to Establish Clinical Utility of Molecular Diagnostics for Precision Medicine: 5 Tips on RCT Design

Healthcare payers, regulators, and physicians focus on clinical utility when evaluating molecular diagnostics tests. Clinical validation — establishing that the test can make a diagnosis or predict clinical outcomes — may not be enough to garner acceptance. This point is crucial, because failure to gain acceptance deprives patients of much-needed health benefits and results in...

Clinical Research: Phase 1 - Phase 4

The Role of Maintenance Therapy in Gynecologic Cancer Treatment

Advanced ovarian and endometrial carcinomas present the greatest challenge in treating gynecologic cancer and, among the five types of female cancers, are responsible for the most U.S. deaths annually.1 With a combination of surgery, chemotherapy, and radiation; patients can go into remission, but the majority will have a recurrence after several months or years. There...

Clinical Research: Phase 1 - Phase 4

Challenges and Opportunities in Gynecologic Cancer Research: Excerpts from a Round Table Discussion

Gynecologic cancers are comprised of five major types: ovarian, uterine, cervical, vaginal, and vulvar. All women are at risk for these, and risk increases with age. Specific risk factors include a family history, human papillomavirus (HPV) infections (cervical cancer), genetic mutations such as BRCA1 and BRCA2 (ovarian cancer or OC), and hormone replacement therapy. Early...

Clinical Research: Phase 1 - Phase 4

FAQs: In Vitro Diagnostic Medical Device Regulation

On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for all previously approved products. The IVDR will replace the EU’s current Directive on in vitro...