Clinical trials are the foundation of medical research, enabling the development of innovative treatments and therapies that improve patient outcomes. In clinical trial documentation, accuracy and integrity are vital in maintaining data quality and patient safety. As we celebrate Healthcare Documentation Integrity Week, it is crucial to highlight the significance of ALCOA+'s principles. "PERI understands that the quality of data collected in clinical research directly impacts research validity. As a CRO (Contract Research Organization), we adhere to CFRs (Code of Federal Regulations) and GCP (Good Clinical Practice) guidelines. The ALCOA+ principle from 21 CFR Part 11 is crucial. ALCOA+ protects document integrity throughout our clinical trial activities," says Chelsea H., Regulatory Affairs Manager. ALCOA is an acronym for Attributable, Legible, Contemporaneous, Original, and Accurate. The updated version of ALCOA+ includes Complete, Consistent, Enduring, and Available. These principles are a guiding framework for keeping data integrity and are widely recognized in regulatory guidelines. The Original ALCOA: Attributable: The ability to trace data back to its source. Every piece of information in clinical trials should be linked to its originator and documented appropriately. Being able to trace data leads to accountability and transparency in data collection, allowing for easy identification of errors, discrepancies, or potential issues during the study. Legible: The importance of clear, readable documentation. Healthcare professionals involved in clinical studies must keep records that are easily understandable and accessible to all stakeholders. Contemporaneous: Contemporaneous documentation requires that data be recorded in real-time as events occur. It discourages retrospective entry, as delayed documentation can introduce errors or bias into the study data. Original: The need to retain the original records and source documents in their true form. Any changes to the data should be documented with a proper audit trail. Retaining original records secures the preservation of the data's authenticity and helps prevent data tampering or unauthorized modifications. Accurate: All documentation, including patient records, adverse event reports, and clinical outcomes, must be precise, complete, and error-free. Not capturing correct data may result in flawed conclusions, compromise patient safety, and hinder the overall integrity of the study. The + Representation in ALCOA+: Complete: Capturing all relevant information necessary to analyze and interpret the study results. Missing or omitted data should be appropriately documented and justified. Consistent: Data should be consistent, guaranteeing that it aligns with other related data sets and does not have conflicting or contradictory information. Discrepancies should be resolved and explained. Enduring: Data stays accessible, retrievable, and unchangeable for the required period, following regulatory and sponsor requirements. Adequate data archiving and storage strategies should be in place. Available: Enabling authorized individuals to access and review the data for analysis, monitoring, audits, or regulatory inspections. "I believe that adherence to ALCOA+'s principles is essential in ensuring the accuracy and reliability of our data. By upholding these, we can confidently generate high-quality evidence for advancing medical knowledge," says Danielle S., Director of Data Management . Joanne R., Quality Assurance Manager, adds, "We have implemented a rigorous Quality Management System (QMS) to ensure compliance with the Code of Federal Regulations (CFR) and ICH-GCP guidelines. By maintaining a Learning Management System Vendor Oversight and Management program as well as a CAPA program PERI strives to continually uphold the highest data integrity and safety standards, fostering trust among stakeholders and supporting the validity of our research outcomes." PERI is committed to upholding data integrity and keeping the highest quality standards in clinical research. Through adherence to ALCOA+'s principles, we can confidently generate reliable evidence and contribute to the progress of medical research. Let's celebrate Healthcare Documentation Integrity Week by recognizing the diligent professionals who champion data integrity in the clinical trial industry, protecting the credibility and impact of their invaluable work.

Cincinnati, OH, May, 1st 2023 - PERI, a leading contract research organization, is proud to announce that its President, Charles Zelen, DPM, along with David Armstrong, DPM, MD, Ph.D., Dr. Dennis P. Orgill, MD, Ph.D., Robert D. Galliano, MD, Paul M. Glat, MD, and Marissa J. Carter, Ph.D., MA, has won 2nd place in podium presentation for SAWC's 2023 highest-scoring abstract for their research with Medaxis. The research, titled "Multicenter, Randomized Controlled Clinical Investigation Evaluating a Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot," is a breakthrough in treating diabetic foot. The study evaluated a unique micro water jet technology device versus standard debridement in treating diabetic foot. The results showed that the micro water jet technology device was more effective than standard debridement in promoting faster healing in patients with diabetic foot. "We are thrilled to be recognized for our research in diabetic foot ulcer treatment," said Charles Zelen, President of PERI. "This study is a testament to our commitment to innovation and finding new ways to improve patient outcomes." The research was conducted in collaboration with Medaxis and involved a multicenter, randomized, controlled clinical investigation with interim results in 50 participants. The study was conducted over 16 weeks and assessed the primary endpoint of complete wound closure at 16 weeks. The secondary endpoints were percent area reductions and the proportion of wounds with at least one infection. The results showed 72% of the Micro Water jet treated DFUs healed compared with 40% treated with standard sharp debridement. In addition, the percent area reduction was 86.5% for the wounds treated with the Micro Water jet versus 35.1% with standard of care, sharp wound debridement. The safety analysis regarding wound-related adverse events (AE) and serious adverse events (SAE) showed 1 AE and 1 SAE occurring in the Micro Water jet group versus 9 AEs and 4 SAEs in the standard-of-care sharp debridement group. The proportion of wounds having at least one infection or cellulitis episode by 16 weeks was 4% in the Micro Water jet cohort versus 24% in the standard of care, wound debridement group. “It is heartening to see more and more data supporting good quality wound preparation. The healing rates we are seeing so far are outstanding. We look forward to further data confirming or refuting these promising findings,” says Professor David G. Armstrong from the Surgery Department at the Keck University School of Medicine. The award-winning research was presented at the SAWC Spring annual meeting, which was held in Prince George's County, MD, on April 28th, 2023. The study is expected to attract significant attention from researchers and medical professionals in the wound healing industry. References 2023. Multicenter, Randomized Controlled Clinical Investigation Evaluating a Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot. [Poster] Symposium on Advanced Wound Care (SAWC) Spring, April 28th, 2033, Prince George's County, MD. About PERI PERI is a contract research organization conducting pre- and post-market clinical trials. The company has extensive experience working with pharmaceutical, biotechnology, medical device companies, and academic institutions. With a team of experienced professionals, PERI is committed to delivering high-quality research services that meet the needs of its clients. For more information, please visit periedu.com. Contact: Kelsea Filter Marketing Manager (513) 230-2645 kfilter@periedu.com