Has your company or site been affected by the transformation happening in the clinical research industry? If it hasn't yet, it probably will be soon.
The shift toward Risk-based Monitoring (RBM) is undeniable; the publication of ICH E6(R2) has only accelerated the transition. Pilot studies have been conducted in which mobile health devices stream subject data directly, in real time, to awaiting EDCs. Large pharmacy chains like Walgreens are acting as recruitment agents and study sites. Virtual, siteless trials are being conducted with more frequency. Protocols are being crowd-sourced. Trial Master Files, Informed Consent, study drug labeling, and source documentation are all going electronic. Drugs with ingestible sensors are being trialed and approved. And social media is giving rise to the empowered patient.
You need GCP experts who have a long history of auditing studies that use traditional research techniques. You also want auditors who keep up with industry trends, and who are ready to adapt their QA activities as your research practices evolve. We do that.
Maybe you specialize in rare disease studies. If you do, you know that regulatory provisions like Orphan Product designations and Expedited Programs were designed to incentivize and accelerate your research. And they can. But they can’t increase your subject pool. With trials so small, you can’t afford to call into question even one subject record; every data point is critical. We’ve audited numerous drug and device studies for rare diseases so we understand that. We also have experience auditing studies under the Fast Track, Breakthrough Therapy, and Accelerated Approval programs.
A trend towards strategic alliances between large sponsors and large CROs means that competition for the services of large, established CROs is likely to increase. Small and mid-sized sponsors can compensate by emphasizing vendor qualification procedures and contracting with smaller, capable CROs or developing strategic partnerships of their own. During a CRO audit we:
Maybe you're following a traditional monitoring approach. Maybe you're testing the waters with a hybrid plan. Or maybe you've transitioned to full-on RBM. No matter your approach, we'll work with you to determine how our site audits can best complement your monitoring scheme, help confirm that it is providing adequate oversight, and help identify refinements you'd like to make for future studies. We can also make sure your sites are prepared for regulatory inspection. During an Investigator site audit, we:
Why wait for an FDA inspection to find compliance issues or deficiencies in your clinical practices? By contacting Polaris today, you can ensure that you have properly implemented the Good Clinical Practices procedures for which the FDA investigators will be looking.
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Polaris Compliance Consultants, Inc.
1151 Executive Circle Suite 202
Cary, NC 27511-4589