I can perform these services at a clinical site, at company headquarters, or as a home-based Clinical Research Associate (CRA).  Sites, CROs, and sponsors can all take advantage of this service at a VERY reasonable cost.  I see companies utilize administrators with limited clinical research experience for regulatory document collection and maintenance.  In the end, regulatory documents always need to be reviewed and oftentimes corrected by a clinical operations specialist who understands the trial, therapeutic area, and compound being tested.  Why not get it right the first time?  Hire an experienced CRA to efficiently oversee your regulatory files and keep your documents in tip-top shape.  You will save money in the end.  My regulatory and study start-up services can be negotiated to fit within your budget and tailored to your needs.  For these types of services, I offer a one-time visit or short-term/part-time contracts.  Routine regulatory review services are available upon request.

Related Services:

Regulatory Compliance services

Some of the regulatory services that I offer include:

 

  • Review, clean-up, and maintenance of sponsor/Clinical Research Organization (CRO) regulatory files
  • Regulatory document collection for study start-up
  • Site regulatory binder maintenance
  • Informed consent writing and maintenance

Contact for Regulatory compliance services

Is your company gearing up for an FDA audit?  Is your site a high enroller and scheduled for a sponsor audit or FDA inspection?  Regulatory document management is my specialty.  I take great pride in regulatory files that are accurate and chronological. 

Regulatory Document Management

Project-based clinical research assistance