December 2020 – Pro-ficiency

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

December 21, 2020/in Press Releases/by Collin Brooks

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/.

Pro-ficiency Appoints Jenna Rouse As VP of Client Success

December 17, 2020/in Press Releases/by Collin Brooks

PRO-FICIENCY APPOINTS JENNA ROUSE AS VP OF CLIENT SUCCESS

This year’s most exciting news! Jenna Rouse has joined the team at Pro-ficiency as the VP of Client Success.

Durham, NC — December 1, 2020

Jenna Rouse has been turning heads and lighting up minds in the training industry since she joined the Association for Clinical Research Professionals (ACRP) 16 years ago. Her expertise in building partnerships and new business opportunities for ACRP quickly led to her development of a strong understanding of the training gaps and needs among CROs, Sponsors and sites within the clinical research enterprise. Her move to Pro-ficiency is a testament to the growth and exciting future of our organization.

“Our company has grown to where it became clear we needed to expand our team to ensure continued outstanding customer support and innovative solutions. I have known Jenna professionally for several years, and when the opportunity arose to bring her onto the Pro-ficiency team, we knew it was a win for the organization, and for our valued clients” –JoAnne Schaberick, Co-CEO at Pro-ficiency.

“I loved working with Pro-ficiency as their client” says Rouse. “The Pro-ficiency platform and simulation programs are truly ground-breaking in the clinical research space and I knew I needed to be a part of a company with that kind of vision”.

Jenna will work with the Executive Sales Team to manage mature, existing and new business accounts, and generate additional business opportunities within that client base. Her attention to high standards and superior client relationships is sure to add to our continual success.

About Pro-ficiency

Pro-ficiency utilizes simulation-training, eMentoring, and analytics to train researchers to the highest performance standards possible. Leading the virtual revolution in remote site support, we provide remote site training, compliance and communication tools to 60,000+ clinical researchers globally. Our virtual toolkit helps study teams meet the challenge of training and communicating with sites.

Initiate trial sites faster and more efficiently and reduce protocol violations with our easy-to-use web-based platform. Learn more at proficiency3.wpengine.com.

Source: Pro-ficiency LLC

Meetings and Slides Are Ineffective for Training Site Staff and Could Increase Patient Risk

December 2, 2020/in Blog/by David Hadden

According to Edgar Dale and dozens of supporting studies, we only retain 30% of verbal information.

Pro-ficiency is based on simulation-training. The same technology employed by airline pilots, surgeons, astronauts, and the military. Imagine if airlines started training their flight crews using meetings and slides!

Both the Pro-ficiency online platform and the simulation-based training content housed there are fully validated and audit-ready according to FDA CFR 21820/11 and ICH/GCP.

Pro-ficiency transforms your study training from an ineffective cost center to a powerful performance management system

• Use the best training for your sites and reduce costs while reducing error

• Play it safe by using validated systems and content that meet 21 CFR 820/11 and ICH/GCP

• Protect patient safety by validating site training content

• Train 100% of all site staff throughout the study

Predictive Analytics (real-time access)

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?

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.

Pro-ficiency Appoints Jenna Rouse As VP of Client Success

December 1, 2020/0 Comments/in News/by Dave Farmer

PRO-FICIENCY APPOINTS JENNA ROUSE AS VP OF CLIENT SUCCESS
This year’s most exciting news! Jenna Rouse has joined the team at Pro-ficiency as the VP of Client Success.

Durham, NC — December 1, 2020

Jenna Rouse has been turning heads and lighting up minds in the training industry since she joined the Association for Clinical Research Professionals (ACRP) 16 years ago. Her expertise in building partnerships and new business opportunities for ACRP quickly led to her development of a strong understanding of the training gaps and needs among CROs, Sponsors and sites within the clinical research enterprise. Her move to Pro-ficiency is a testament to the growth and exciting future of our organization.

“Our company has grown to where it became clear we needed to expand our team to ensure continued outstanding customer support and innovative solutions. I have known Jenna professionally for several years, and when the opportunity arose to bring her onto the Pro-ficiency team, we knew it was a win for the organization, and for our valued clients” –JoAnne Schaberick, Co-CEO at Pro-ficiency.

“I loved working with Pro-ficiency as their client” says Rouse. “The Pro-ficiency platform and simulation programs are truly ground-breaking in the clinical research space and I knew I needed to be a part of a company with that kind of vision”.

Jenna will work with the Executive Sales Team to manage mature, existing and new business accounts, and generate additional business opportunities within that client base. Her attention to high standards and superior client relationships is sure to add to our continual success.

About Pro-ficiency

Pro-ficiency utilizes simulation-training, eMentoring, and analytics to train researchers to the highest performance standards possible. Leading the virtual revolution in remote site support, we provide remote site training, compliance and communication tools to 60,000+ clinical researchers globally. Our virtual toolkit helps study teams meet the challenge of training and communicating with sites.

Initiate trial sites faster and more efficiently and reduce protocol violations with our easy-to-use web-based platform. Learn more at proficiency3.wpengine.com.

Source: Pro-ficiency LLC