ALCOA+'s Principles & Healthcare Documentation Integrity Week

May 18, 2023

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.

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PERI Announces Award-Winning Research on Diabetic Foot Treatment

01 May, 2023

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

Compedica Publishes Positive Results in a Single Arm Prospective Feasibility Study Evaluating the Safety and Efficacy of OptiPulse™ active therapy system in the Treatment of Diabetic Foot Ulcers.

By Professional Education & Research Institute, LLC • 26 Sep, 2022

The Professional Education and Research Institute, LLC (PERI), a Clinical Research Organization that specializes in Phase 1 through Phase IV clinical trials for biologics, drugs, and devices, is thankful for the opportunity to work with Compedica Limited: United Kingdom (Compedica), a medical device company, on the OptiPulse™ active therapy system (Compedica Limited; United Kingdom) clinical trial recently published in the International Wound Journal. (https://onlinelibrary.wiley.com/doi/full/10.1111/iwj.13932) In this single-arm prospective feasibility study, trial subjects with Wagner grade 1 non-healing diabetic foot ulcers were treated with the OptiPulse™ active therapy system (Compedica Limited; United Kingdom) and 80% healed within 12 weeks. As a result, wound healing accelerated, and pain improved for trial subjects.1 Dan Blackman, Chief Operating Officer of Compedica states; “These results are very exciting and support our belief that mobile intermittent plantar compression combined with offloading and patient monitoring can have significant benefits to healing DFUs. We are pleased to continue our work with PERI to build on these promising initial findings.” OptiPulse™ active therapy system (Compedica Limited; United Kingdom) is a device designed to offload the wound, enhance circulation, and monitor patient compliance. The study, “A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non-healing diabetic foot ulcers,” evaluated the safety and efficacy of the OptiPulse™ active therapy system (Compedica Limited; United Kingdom) for 10 patients with non-healing DFUs for up to 12 weeks. The primary endpoint was complete wound closure at 12 weeks, and secondary endpoints included healing time, percent area reduction, and changes in pain using the visual analog pain scale. Eight out of ten wounds healed within 12 weeks (80%), and the mean healing time was 41 days(95% CI:24.3–58.3). The percent area reduction was 75(SD:53.9). The baseline visual analog pain scale was 4.5(2.9) as compared with 3.3(3.4) at the end of the study. No device-related or serious adverse events were reported. 1 In conclusion, this unique intermediate plantar compression and offloading device may be considered an alternative for the safe and effective treatment of non-healing diabetic foot ulcers. Sources: 1. Armstrong DG, Orgill DP, Glat PM, et al. A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non-healing diabetic foot ulcers. Int Wound J. 2022;1‐8. doi:10.1111/iwj.13932

Bioventus Publishes Positive Results in a Randomized Controlled Trial Evaluating TheraSkin Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

06 Jul, 2022

The Professional Education and Research Institute (PERI), a Clinical Research Organization that specializes in Phase I through Phase IV clinical trials for biologics, drugs, and devices, is grateful for the opportunity to work with Misonix Inc. now Bioventus, a global biotechnology company on the Theraskin trial recently published in the International Wound Journal ( https://onlinelibrary.wiley.com/doi/10.1111/iwj.13759 ). Briefly, in this Level one clinical evidence trial subjects with non-healing ulcers treated with TheraSkin in addition to Standard of Care (SOC) wound treatment had significantly improved healing versus SOC treatment alone. Alan Staley the former president of Misonix, states; “this landmark trial compliments our already existing science and publications on this unique living cell graft.” TheraSkin is a split thickness allograft (BSA) that, in combination with SOC, has the potential to improve wound healing in Diabetic Foot Ulcers drastically. The study " A Multi-centre prospective randomized controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers" compared the response of 100 subjects with non-healing DFUs. Fifty subjects were treated with a cryopreserved bioactive split thickness skin allograft (BSA) (TheraSkin; Bioventus) alone with appropriate standard wound treatment compared with 50 subjects treated with standard of care alone (collagen alginate dressing) for 12 weeks The primary endpoint was the proportion of full-thickness wounds healed at 12 weeks, with secondary endpoint that include differences in percent area reduction (PAR) at 12 weeks,. The results illustrated in the intent-to-treat analysis at 12 weeks showed that 76% (38/50) of the BSA-treated DFUs healed compared with 36% (18/50) treated with SOC alone (adjusted P = .00056). In addition, the mean PAR at 12 weeks was 77.8% in the BSA group compared with 49.6% in the SOC group (adjusted P = .0019). In conclusion, adding BSA to SOC appeared to significantly improve wound healing with a lower incidence of treatment-related adverse events compared with SOC alone. Sources: Armstrong DG, Galiano RD, Orgill DP, et al. Multi-centre prospective randomised controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers. Int Wound J. 2022;19(4):932-944. doi:10.1111/iwj.13759