Phillips MediSize - Cheryl Norder

Inspired by Your Challenges

At Clinical Research Strategies, we are inspired by the complexity of the problems we solve for our life sciences clients.

We have a powerful team of experienced device veterans in the highly complementary disciplines of regulatory strategy, quality assurance, risk management, and clinical operations who know how to de-risk programs. And we see each challenge as an opportunity to improve the chances of clearing performance hurdles toward successful commercialization or exit.

Is your success riding on a shoestring budget?

We’ve been there. We know exactly what it’s like. Our team handles the entire development and execution process with eff ective competency, high quality, and at a reasonable cost. The CRS team is prepared to tackle your biggest challenges and help you thrive.

Clinical Research Strategies’ top service areas include medical device (class I-III), IVD, SaMD, and Federated Medicine: • Design, V&V, QMS, and Risk Management • Regulatory Pathway Assessments, Regulatory Submissions • 483 and Warning Letter Remediation • Medical Writing, Literature Reviews, and Clinical Evaluations • Clinical Operations, Clinical Trials, Human Factors & Usability • Privacy and Corporate Compliance • Trial Master Files (TMFs), Inspection-Readiness, GxP Audits • Advisory Boards, Safety Committees

Contact Clinical Research Strategies today, and let’s talk about the challenges that are keeping you up at night!

Contact Compliance Award-Winner, Alethea Wieland, founder, president & COO of CRS, for a free 30-minute, no-obligation consultation by visiting ClinicalResearchStrategies.com.