SOURCE: OV Clinical Trials

OV Clinical Trials

April 20, 2011 09:18 ET

FDA Warning Letters Reveal a Need for Site Clinical Trials SOPs

DENVER, CO--(Marketwire - Apr 20, 2011) - OmniaVincit (OV), a division of OV Clinical Trials, reported today the release of immediately downloadable, GCP-compliant, clinical trials SOPs for investigator sites.

"The need for GCP-compliant SOPs for clinical trials is more important than ever. In the face of the FDA's proposed rule for expanding the scope of clinical investigator disqualification, investigator sites need to ensure compliance under increased FDA scrutiny. Additionally, with stricter sponsors' investigator site selection criteria and reduced product pipelines, investigator sites are looking for ways to differentiate themselves," stated OV CEO Dr. Debbie Wilkerson.

OV recently carried out a review of all Food and Drug Administration (FDA) warning letters issued to clinical investigators for both drug and device studies between 01JAN2010 through 14MAR2011. There are many areas that clinical investigators are consistently falling behind on, and sponsors and regulatory agencies are beginning to take notice. The issues include failing to:

  • Conduct the study in accordance with the protocol/investigator agreement,
  • Maintain adequate records,
  • Obtain proper informed consent,
  • Correctly submit to regulatory authorities, and
  • Protect subjects.

Many of these issues could be avoided if clinical investigators had clinical research SOPs in place and followed them. The findings from these FDA warning letters could put the clinical data at risk and could therefore affect the power of the study, generalizability of the results, and may even end up impacting the approvability of the investigational product.

"The creation of clinical trials standard operating procedures for clinical investigator sites is something that is often a huge burden on time and resources," states OV COO Dr. Gizelle Baker. "That is why we are following our company mission to create more efficient clinical trials by offering low-priced, fully GCP-compliant, customizable SOP templates as a starting point for sites. We work with sites to help them customize and implement the clinical research standard operating procedures so that the SOPs reflect how the site operates, while ensuring that they are compliant with the regulations."

SOPs establish standards for those responsibilities that regulatory authorities have attributed to the investigator to support compliance with clinical research regulations and guidances. SOPs improve communication among staff, reduce dependence on individuals with institutional knowledge, and improve efficiency of staff training.

About OV Clinical Trials

OV Clinical Trials is a Denver-based clinical service organization, which has developed clinical research SOPs, training curriculums and site accreditation/auditing to ensure the clinical research is conducted correctly and the clinical data is valid from the source (the investigator site) all the way through analysis and submission. SOPs provide the foundation of a good quality system. OV Clinical Trials works with drug, biologic and medical device companies and investigator sites engaged in all phases of product development. For more information, visit

Contact Information

  • For Further Information, Contact:
    Gizelle Baker
    OV Clinical Trials
    p. 303-223-2320
    Email Contact