The regulatory department at Research Centers of America works alongside sponsors and CROs from site selection through study close-out, confirming consistency and compliance through the trial life cycle.
Our site personnel have experience in handling all aspects of the regulatory process including ICF writing, preparation of essential documents in accordance with ICH GCP guidelines, expedited reviews, translations, and maintenance and close-out requirements.
RCA utilizes a certified translator and certification of accuracy for expedited Spanish translation of study documents. Study regulatory binders are maintained in a secure and monitored area during study conduct and upon completion are archived at an off-site location, with a retrieval timeline of 48-72 hours. We are committed to conducting our clinical trials with integrity and placing subject safety above all else.
- Rapid start-up submissions (within a week) that can be expedited as needed
- Bilingual: Investigators, clinical raters, and study staff
- Experience with use of central and local IRBs
- Prepare and submit regulatory material to ensure timeliness and compliance with IRB standards.