Featured Articles
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Designing Robust Gene Therapy Studies
6/7/2022
Explore the key considerations for designing successful gene therapy trials in the available blog.
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Pursuing The Promise Of Gene Therapy: Pathways To Successful Clinical Trials
6/7/2022
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. Explore the emerging landscape of gene therapy and high-level considerations for studies of these advanced therapeutics in this blog.
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Excerpts From A Round Table Discussion: Challenges And Opportunities In Gynecologic Cancer Research
5/5/2022
Find out how recent approvals of targeted therapies have led to meaningful improvements in patient care and outcomes and have also stimulated research, particularly in combination trials.
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Empowering Oncology Patients: Recruitment And Retention Strategies For Optimizing Study Outcomes
5/5/2022
In this blog post, learn about the strategies sponsors should consider during the study planning process to maximize patient engagement and retention.
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Maximizing Oncology Study Outcomes: Overcoming Enrollment Challenges In A Phase 2 Prostate Cancer Clinical Trial
5/5/2022
Dive into this case study to see how a U.S.-based developer of an investigative therapy for mCRPC was able to increase enrollment in a Phase 2 mCRPC study involving 100 patients at six sites in the United States.
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The Role Of Maintenance Therapy In Gynecologic Cancer Treatment
5/5/2022
Discover the critical unmet need for better maintenance therapies to improve the quality of life and to achieve improvement in the overall survival for women with advanced ovarian and endometrial carcinomas.
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How To Establish Clinical Utility Of Molecular Diagnostics For Precision Medicine: 5 Tips On RCT Design
4/12/2022
Healthcare payers, regulators, and physicians focus on clinical utility when evaluating molecular diagnostics tests. However, establishing that the test can make a diagnosis or predict clinical outcomes may not be enough to garner acceptance. Explore ways to approach designing and conducting a randomized clinical trial (RCT) to demonstrate clinical utility.
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IVDR Survival Guide: Know The 4 Main Challenges And How To Overcome Them
4/7/2022
Walk through the four primary challenges to In Vitro Diagnostic Regulation (IVDR) conversion and discover solutions to simplify and de-stress the process so that IVD manufacturers can approach deadlines confidently and avoid having products pulled from the market.
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FAQs: In Vitro Diagnostic Medical Device Regulation
4/6/2022
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). Discover answers regarding the expected changes in this blog.
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Engineering A PMA Study For A First-Of-Its-Kind Oncology Dx
3/8/2022
A client developed a unique solution for Colorectal cancer screening – a multi-target, noninvasive screening test that could be facilitated by patients in their homes. Gather information on how the pre-market approval (PMA) study was conducted.