Regulatory/IRB Management

Dedicated Regulatory Support

Our site is supported by an on-site dedicated and experienced regulatory team that interfaces with the clinical team and our local IRB to ensure pristine and timely submissions. This method ensures a timely turnaround time of Regulatory Documents.

Study Process and Expertise

Feasibility Assessment

Our study teams and management work together to perform an in-depth analysis of all protocols prior to accepting any new trial. We want to ensure that we have the sufficient population to maximize recruitment during the proposed study timeline. This process continues throughout the conduct of the trial as we constantly discuss and evaluate enrollment and if warranted, implement new or improved recruitment plans.

Dedicated, Skilled Coordinators

Experienced and driven Clinical Research Coordinators are integral to the success of any trial. The CTC offers talented specialists to consistently exceed your expectations. Our Clinical Research Nurses and Coordinators are highly trained on our own internal SOPs as well as GCP and FDA guidelines. All coordinators are certified by either ACRP or SOCRA and are provided with on-going and advanced state of the industry training. Our research coordinators are experienced in managing all aspects of a particular trial. Best of all, they are creative problem solvers in their continuing efforts to improve local recruiting strategies.

Experienced, Focused Investigators

The VA Pittsburgh Healthcare System boasts a superior team of motivated and focused investigators who offers clinical trials experience in a wide range of therapeutic areas. They are thought leaders who are published in leading journals and are frequent speakers. As leaders in their specialized fields, their insights move clinical research to a higher level. Our knowledgeable investigators enthusiastically embrace clinical research and the opportunities that new therapies bring to the marketplace and veterans. Dedication and experience aside, our investigators are also highly trained in GCP and FDA regulations.

Each Investigator participates in the VAPHS’ ongoing internal investigator training program. Our investigators go the extra mile to ensure smooth conduct of your clinical trial. In addition to protocol-specific responsibilities and GCP/FDA requirements, you can count on our physicians to attend investigator meetings, actively recruit patients from their clinic, meet with CRAs during monitoring visits and offer qualitative feedback regarding your clinical trial. All of our investigators share the goal of providing you with accurate, high-quality data.

Site Services

Electronic Medical Record System

The VA’s EMR is one of the top rated in the country. The EMR follows the subject across the VA medical system and gives us the access needed to ensure all adverse events are captured appropriately as well as dramatically reduces the number of lost to follow-up subjects.

Networking Opportunities

Working with our site allows a sponsor access to the country’s largest integrated health care system. Once you have executed the VA’s Cooperative Research and Development Agreement (CRADA) with one site, you may use that template to work with any other VA Medical Center.

Dedicated Clinical Trial Space

In 2012 the VA Pittsburgh Healthcare System erected a $27.3 million state of the art Research Building. This building provides approximately 6100 square feet of designated clinical trial examination space which includes 4 fully equipped exam rooms, area for sample collection and processing as well as storage. We also provide access to private monitoring rooms. Additionally, we offer a dedicated Investigational Drug Service as well as a fully equipped CLIA and CAP certified laboratory.

The Veteran Health Enhancement Research Testing (VET-HEART) Center is embedded within the CTC. It is a service that provides a range of functional testing services to VA investigators. VET-HEART is staffed by a team of ACLS-credentialed personnel (cardiologists, nurses, and exercise physiologists). A defibrillator and code cart are maintained in the immediate vicinity. Some of the testing/procedures include:

  • ECG Exercise Stress testing
  • Cardiopulmonary Exercise Testing
  • Six Minute Walk Test
  • 400 Meter Walk
  • Gait speed
  • Timed Up and Go Test
  • Hand Grip Strength

  • Sit to Stand Test
  • The Short Physical Performance Battery
  • Muscle Strength and Fatigability
  • Skeletal Muscle Biopsies
  • Pulmonary function test
  • Exercise Training

FAQs