Academic CRO Strengthens Compliance

Academic CRO Strengthens Compliance

Toward the end of a long winter, an internationally renowned academic clinical institution based in Philadelphia, Pennsylvania, chose Cerulean Associates LLC to provide a full review and compliance gap assessment of its FDA data integrity and HIPAA security controls. The organization was on the cusp of rapid growth, running multiple clinical trials for its customers and business partners, and needed trusted expertise that would provide clear insights and practical recommendations.

“We chose Cerulean in large part because of the excellent references from so many of Cerulean’s former clients. Cerulean’s John Avellanet really understood what we needed and helped us better understand the breadth of the institution’s responsibilities around FDA and HIPAA compliance. Not only was Cerulean very thorough in its approach and recommendations, Cerulean also provided us a number of helpful resources and cost-effective suggestions, going above and beyond the scope of work to ensure we succeeded.”

– V. Cherington, Director, Scientific Administration, Philadelphia, Pennsylvania

At Cerulean, our clients come first. When you’re ready for trusted expertise, pragmatic solutions, and cost-effective compliance, all designed to make sure you succeed, contact Cerulean.

We provide these customized services to our clinical clients:

  • Data integrity controls gap assessments
  • Clinical data system and validation reviews
  • Data integrity controls and auditing workshops and training
  • FDA recordkeeping reviews and audits
  • Policy and SOP writing and streamlining
  • FDA inspection preparation and FDA-483 remediation

If you need to verify your clinical controls and strengthen your compliance, contact Cerulean today.