November 2020 – Pro-ficiency

FOR IMMEDIATE RELEASE

For More Information, Contact:
Barbara Getz
305-370-5708
bgetz@tissuetechinc.com

TissueTech Announces Engagement of Pro-ficiency Virtual Study Trainer™ for Clinical Trials

Miami, FL – November 19, 2020 – TissueTech, Inc., an emerging biotechnology company and pioneer in the clinical application of cryopreserved amniotic membrane and umbilical cord birth tissue allografts, announced today the engagement of Pro-ficiency Virtual Study Trainer™ to facilitate remote study protocol training for TissueTech’s clinical trial investigators and their clinical research teams.

TissueTech has been quick to integrate proven technologies to meet the rapidly changing clinical trial industry landscape during the pandemic and maintain compliance with FDA guidance. Even in the best of times, effectual training on complicated protocols is a challenge. Ensuring investigator compliance with regulatory guidelines is paramount to building a foundation for any successful trial. Recognizing the costs and risks associated with face-to-face training and needing a proven solution, TissueTech selected Pro-ficiency to ensure success in their late-breaking Diabetic Foot Ulcer study in this new operating environment.

“As we were evaluating ways to leverage innovative technologies to solve some of the challenges faced with launching late-breaking trials amidst the onset of the pandemic, investigator training was a specific area of focus and concern,” said Tommy Lee, Vice President of Clinical Operations at Tissue Tech. “Pro-ficiency uniquely stood out from the available options providing critical measures of protocol understanding through simulation training. This method was very attractive as it optimized the investigator’s ability to learn through immersive and engaging real-world scenarios designed to test their understanding of the trial’s protocol.”

Pro-ficiency’s Virtual Study Trainer ™ uses the most advanced Remote Site Performance Management technology in the industry. Offering both Virtual IM™ and Virtual SIV™, Pro-ficiency aids in avoiding the cost and complexity of travel and scheduling and training every investigator and site staff to the highest performance standards possible. Remote learning at Pro-ficiency utilizes simulation-training and remote site performance management, ensuring virtual training is just as effective as the face-to-face alternative.

Pro-ficiency CEO David Hadden says: “We are proud to be working alongside TissueTech on a meaningful, innovative project targeting an unmet medical need in diabetic patients living with complex diabetic foot ulcers and in need of advanced wound management.”

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue, Inc., is a scientific and market leader in the field of regenerative medicine. TissueTech manufactures a broad range of ocular, surgical, wound care, and soft tissue products that are marketed under these subsidiaries. Since the company’s inception, clinicians have performed more than 500,000 human implants of the company’s products and published more than 360 peer-reviewed studies supporting its platform technology. TissueTech is committed to an unwavering culture of integrity that places our patients’ safety and clinical outcomes above all else. Learn more at https://tissuetech.com/.

GCP and Pharmacovigilance training is a requirement for all sites that participate in clinical trials. Non- compliance with ICH GCP E6(R2) regulations results in inspection findings, cost overruns, data rejection, and potential study delays. As a result, sponsors often require that sites take their specific GCP and PV training, so investigators wind up taking the same training again and again. These modules are often delivered face-to-face at sites with slides or through eLearning. Research shows that we only retain 20% to 30% of verbal information whereas with simulation / experiential learning, we retain 70% to 90%.

The Pro-ficiency GCP and PV training uses real-life scenarios in an online simulated environment. The better the learners know the material and the more they pay attention to the training, the faster they can get through it. Like in a choose-your-own-adventure novel, site staff make their way through realistic scenarios that cover the principles of GCP and PV in an entertaining way.

In fact, 76% of 1701 site staff learners “Liked” or “Loved” the Pro-ficiency simulation-based GCP training while 20% said is “OK” and only 4% preferred eLearning or face to face training. We are doing something right when thousands of investigators tell us that they LOVE our GCP training!

This Pro -ficiency training is an improvement on traditional training (meetings, slides, videos).

83% agree

10% undecided

7% prefer traditional methods

Predictive Analytics (real-time access)83% agree

The Pro-ficiency dashboard shows investigator performance in the training simulations across dozens of critical protocol and GCP metrics (the vertical columns). A blue checkmark indicates that a specific decision was made appropriately. If the learner makes a mistake, then a brief video -based corrective action is launched and they get a yellow icon. If the learner makes that same mistake again, they get a red icon. Lots of yellow icons indicate that, while knowledge gaps were identified, they were also easily corrected. Lots of red icons means those investigators are either not trying or they are having real problems understanding the protocol.

Based on the performance of the 2 sites above, which one would you trust more with your protocol and expect better performance from? 7% prefer traditional methods

David Hadden

Dave Hadden is an entrepreneur and technology innovator, founding Pro-ficiency and pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Patient Simulation (VPS). Dave has focused his passion for technological innovation and learning systems in the field of clinical trials, helping sponsors make their studies more accurate and efficient through finding the right technology mix such as virtualization, performance management and applied behavioral sciences to produce the most effective, lasting, and engaging results for clinical trials.