Fee for Service / OCR Regulatory
Fee For Service Research Cores
The following are fee for service cores that can assist researchers with specific aspects of clinical research work. Typically these may be most useful for sponsor investigators and/or those conducting investigator initiated research work.
OCR Regulatory
OCR Regulatory provides subject matter expertise to faculty conducting (i) investigator initiated clinical trials, (ii) non-clinical IND enabling studies, and (iii) manufacturing for use in clinical trials, which make up the key components of a regulatory submission. In addition, the OCR Regulatory team can help you with early interactions with the FDA and serve as the regulatory lead for your IND or IDE.
For an estimate on regulatory services please contact OCR Regulatory or call 215-662-4484.
Services
Regulatory staff is available to help PSOM Faculty prepare for meetings (e.g., pre-submission IND or IDE, Informational, Determination, etc.) with Health Authorities (e.g., FDA, etc.) as well as regulatory submissions. Work with our experienced team utilizing our IND, IDE, Protocol, and IB templates for preparing and electronically maintaining your IND or IDE with the FDA.
All IND, IDE and CTA Sponsors require study oversight. Sponsors are responsible for ongoing submissions to Health Authorities that include protocol amendments, investigational product manufacturing changes, safety reports, and annual reports. Other responsibilities include periodic progress reports to investigators and other regulatory entities (as applicable). The OCR Regulatory staff is available to support and provide guidance to faculty who need assistance with regulatory sponsor responsibilities. The OCR Regulatory team is experienced with vendor qualification, sponsor team qualification, management of fCOI, Clinical Trials.gov, and compiling and maintaining an inspection ready Trial Master File.
Sponsor Qualification, Registration, and Training
To review the Required Qualifications, Registration, and Training to be a Sponsor or Sponsor-Investigator at the PSOM, please see IND/IDE/CTA Sponsor Training . For more information, contact OCR Regulatory via email or by calling 215-662-4484.