2^nd International Conference on Clinical Trials August 22-24, 2016 Philadelphia, Pennsylvania, USA

Biography:

Thomas E Serena is the Founder and Medical Director of Serena Group™, a family of wound, hyperbaric and research companies. He completed his residency in Surgery at the Hershey Medical Center. To date he has opened and operates wound care centers across the United Sates and globally. He has been the lead or Principal investigator in over 100 clinical trials and is recognized internationally as an expert in the field of wound healing: He has more than 100 published papers and has given more than 1000 invited lectures throughout the world. He has been a Member of the Board of Directors of the Wound Healing Society and served two terms on the board of the Association for the Advancement of Wound Care (AAWC) and is at present the President-Elect. He has also been Vice-President of the American College of Hyperbaric Medicine and President of the American Professional Wound Care Association.

Abstract:

Clinical research is an essential component of Serena Group’s™ Center-of-Excellence model for wound and hyperbaric centers. We are one of the world’s leaders in clinical research on wound care and hyperbaric medicine, having conducted over 100 clinical trials involving growth factors, gene therapy, bioengineered skin products, and novel pharmaceuticals. In 2011 Serena Group™ clinics conducted the research that led to the first diagnostic in wound care. The ensuing manuscript named the diagnostic procedure the Serena Technique©. In conjunction with Harvard’s Wellman Institute we developed and performed the initial clinical studies on a painless, bedside epidermal skin-harvesting device that is functioning not only in hospitals in the US but in third-world clinics as well. Our emphasis on clinical research over the years has drawn a group of young clinicians and scientists to participate in our research projects in the US and internationally, who are dedicated to advancing the science of wound healing. We formed the nation’s first wound healing cooperative group consisting of more than 30 centers in the US and worldwide that now conducts entire multi-national clinical trials. In 2015 Serena Group Innovation™ opened a laboratory at Northeastern Ohio Medical School to conduct preclinical studies in wound healing. The research team has filed numerous patents as a result of these efforts.

Biography:

Dr. Entsuah is a Fellow of the American Statistical Association and presently an Executive Director of Late Development Statistics at Merck Research Labs and Head of Research Group 4 (Neuroscience, Respiratory and Immunology areas). Previously, he was an Assistant Vice President of Biostatistics at Wyeth Research Labs (Pfizer). Prior to joining the industry in 1988) he was an Assistant Professor of Biometry at University of Illinois in Chicago. Dr. Entsuah has published extensively both in statistical and clinical journals and has given many presentations over the years. He has led approval of various compounds as the statistical lead and has been an invited seminar presenter at the US FDA.

Abstract:

A longitudinal mixture model for classifying patients into responders and non-responders is established using both likelihood-based and Bayesian approaches. The model takes into consideration responders in the control group. Therefore, it is especially useful in situations where the placebo response is strong. Under our model, a treatment shows evidence of being effective if it increases the proportion of responders or increases the response rate among responders in the treated group compared to the control group. Therefore, the model has flexibility to accommodate different situations. The proposed method is illustrated using simulation and a depression clinical trial dataset for the likelihood-based approach, and the same depression clinical trial dataset for the Bayesian approach. The likelihood-based and Bayesian approaches generated consistent results for the depression trial data. In both the placebo group and the treated group, patients are classified into two components with distinct response rate. The proportion of responders as shown to be significantly higher in the treated group compared to the control group suggesting the treatment paroxetine is effective.

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Biography:

Ayad K Abdul-Ahad continued his speciality training in the UK in Immunology and Oncology after obtaining his medical degree,. He obtained, the PhD, MSC, MRCPath and FRCPath. His areas of interest included Immunotherapy and BMT. Over the past 24 years he worked in the Biopharmaceutical industry, across the US and Europe, during which he built and lead Medical Affairs and Clinical Development in companies, such as Serono, Berlex, Biogen and Astellas. Ayad also pioneered cancer immunotherapy by treating the first ever patient with a therapeutic antibody for cancer. He is regarded as a Medical Leader by the World leading experts in MS

Abstract:

BOTh analyzes daily patient safety on a clinical study. It provides a more accurate reflection of the burden of treatment than current safety methods and facilitate informed treatment selection. Patient-level safety data was utilized to quantify the daily burden of adverse events by severity on a per patient and per day basis, and presented using a chart. Data from two published studies in peripheral neuropathic pain (PNP) and overactive bladder (OAB) were utilized. In the PNP study, the overall BOTh graph showed a difference in AEs in the two treatment groups.The topical TRPV1 agonist group showed an initial peak followed by a rapid decline in AEs per day, due primarily to transient application site reactions.The oral anticonvulsant group, showed a gradual increase, followed by a consistent number of AEs to the the study end. The overall burden (area under the curve) was 61.2 for the oral anticonvulsant and 23.5 for the topical TRPV1 agonist (p<0.0001).The integration of safety and efficacy into the graph allowed the safety burden comparison with the median time to treatment response. In the OAB study, the overall burden were similar between the two groups. An analysis of patients with dry mouth revealed that more patients reported it in the antimuscarinic group p=0.02. BOTh provides visual representation and statistical analyses of the burden of medication in individual patients or subgroups combining tolerability and efficacy. BOTh allows sensitive, clinically relevant analysis than current methods, which show an overall summary not reporting pateints with more than one AE over time.

Biography:

Suyu Liu is an Assistant Professor at the UT MD Anderson Cancer Center. Her current research focuses on the development of novel adaptive designs for clinical trials. Examples include phase I trial designs to find the maximum tolerated dose (MTD), Phase I/II designs to find the recommended dose accounting for both toxicity and efficacy, dose-finding designs that accommodate late-onset toxicities and biomarker-based adaptive designs for targeted therapy development. She has published more than 30 papers in reputed statistical journals and medical journals.

Abstract:

Interval designs are a class of phase I trial designs for which the decision of dose assignment is determined by comparing the observed toxicity rate at the current dose with a pre-specified (toxicity tolerance) interval. If the observed toxicity rate is located within the interval, we retain the current dose; if the observed toxicity rate is greater than the upper boundary of the interval, we deescalate the dose; and if the observed toxicity rate is smaller than the lower boundary of the interval, we escalate the dose. The most critical issue for the interval design is choosing an appropriate interval so that the design has good operating characteristics. By casting dose finding as a Bayesian decision-making problem, we propose new flexible methods to select the interval boundaries so as to minimize the probability of inappropriate dose assignment for patients. We show, both theoretically and numerically, that the resulting optimal interval designs not only have desirable finite- and large-sample properties, but also are particularly easy to implement in practice. Compared to existing designs, the proposed (local) optimal design has comparable average performance, but a lower risk of yielding a poorly performing clinical trial.

Biography:

Michael Bernstein is Vice President of Global Compliance and Risk Management at Clinical Supplies Management, Inc. He is responsible for the oversight of CSM's global compliance, risk management, process excellence and quality programs. He has over 28 years of Compliance experience in the pharmaceutical industry. Prior to joining CSM, he held various R&D, Manufacturing and Global Compliance positions during his 26-years at Merck & Co. Inc.

Abstract:

FDA’s “Paving the Way for Personalized Medicine” reports along with the funding of the Precision Medicine Initiative are changing the clinical drug development landscape in the United States. Drug development stratification has resulted in numerous drugs being developed for small geographically dispersed patient populations with fewer clinical investigators participating in the clinical studies. This creates a challenge for patients who cannot travel long distances to obtain their clinical medication. DtP shipment of clinical trial material is a potential solution that addresses various challenges introduced by the Precision Medicine Initiative. The objective of this paper is to provide guidance and best practices for study sponsors and clinical investigators wanting to utilize the DtP distribution model for their clinical studies. The author reviewed various regulations, guidance documents and case studies pertaining to DtP distribution of clinical trial material and identifies regulatory and compliance considerations when using the DtP distribution model. There are multiple regulations and guidance documents pertaining to clinical studies but none specifically address the DtP distribution model. Sponsors wanting to utilize DtP distribution in their clinical trial must ensure they get proper buy-in from key stakeholders including Principal Investigators, IRB’s, CRO’s and the patients. Sponsors must develop a clear concise investigation plan incorporating DtP distribution language in their regulatory documents. They must have early transparent dialog with regulators and ensure their plan addresses any concerns the regulators may have.

Biography:

C. C. Chu, the Rebecca Q. Morgan endowed chair professor, is a biomaterial scientist/engineer at Cornell University since 1978. Chu is the recipient of the State University of New York Chancellor’s Award for Excellence in Scholarship and Creative Activities in May, 2009. Chu was very recently inducted into the College of Fellow of the American Institute of Medical and Biological Engineering on March 24, 2014. Chu also served on the Biology/Medicine Panel of the Hong Kong Research Grant Council from 2010 – 2013. Chu has 200 research papers/book chapters, 3 books and 68 US/international patents with 7,665 citations and h-index 50.

Abstract:

A mast cell stabilizer (Ketotifen, KF) doped new biodegradable nano-fibrous membrane fabricated from a new synthetic amino acid-based poly(ester amides) (AA-PEA) and absorbable polycaprolactone (PCl), and hybrid hydrogels from Arg-PEA/chitosan derivatives were evaluated for wound healing characteristics of a 2^nd degree burn as well as full-thickness excision injury of a porcine model at 7, 14, and 21 days post-injury. The characteristics of the wound treated with the new biomaterials were evaluated in terms of tissue inflammatory responses and scar tissue formation. Wound tissues harvested were histologically evaluated for collagen content, type, mast cell and macrophage. Macrophages in tissue sections were labelled with ionized calcium binding adaptor molecule 1 (IBA1) and DAB as the chromagen. The proportion of type I vs. type III collagen was determined from photomicrographs of Pico Sirius Red stained slides illuminated with circularly polarized light, the ratio of yellow/red pixels to green pixels was determined using Fiji. Assay data were analyzed using ANOVA and appropriate post hoc tests for potential differences in time and/or treatment effects on wound HP content. Treatment of burns with the mast cell stabilizer-doped nano-fibrous membrane resulted in a lower wound hydroxyproline content than undoped membrane- or Silvadene-treated wounds, suggesting that the membranes themselves did not invoke a significant inflammatory reaction. Both IBA-1 and positive pixel count data of macrophage confirm that the KF-doped nanofibrous membranes showed lower numbers of macrophage (i.e., inflammation) than both the non-doped and Silvadent-treated burn wounds. There were no statistically significant differences in HP content between excision-wounded untreated and wounded hydrogel-treated groups, suggesting that the Arg-PEA hybrid gels did not induce significant inflammation.

Biography:

Joe Martinez serves as the CEO of Center Point Clinical Services. He brings over 30 years of successful leadership experience in the pharmaceutical, biotech and Medicaid industries. He instituted novel industry programs utilizing RWE (real world evidence) and health outcomes information to communicate product value information to health care decision-makers. His research abstracts and poster presentations have been accepted by national and international associations including ADA, ASCP, AMCP, AGS, AADE and AACE.

Abstract:

Successful clinical trials are critical to compiling the medical and clinical data that are required for FDA review and approval of a drug, device or procedure application. Frequently cited problems that have a direct impact on these clinical trials are patient enrollment, patient medication compliance and patient retention. When these retention issues prolong a clinical study, each extra day can cost a company $37,000 in additional operating costs and $1.1 million in lost revenues according to a Tufts Center for Study of Drug Development Impact Report. Observing a series of four clinical studies completed for one chronic disease (diabetes) medication where pharmacist medication counseling services were provided: 92.8% (2,900 of 3,124) of patients had at least one intervention, 991 (31.7%) patients had a concurrent medication usage intervention. Patients responding to a survey about their satisfaction and their interactions with the pharmacist over the phone indicated: 94.7% of respondents either strongly agreed or agreed that phone conversations with the pharmacist helped them to further understand how to use the study medication, 90.0% of respondents either strongly agreed or agreed that they appreciated the follow-up phone call from the pharmacist due to a missed dose or issues with the IVRS, and 96.3% of respondents either strongly agreed or agreed that they were more comfortable with participating in the trial knowing that a pharmacist was available to answer questions. Pharmacist medication counseling in clinical trials can provide positive strategic clinical support and is well received by the patients.

Biography:

Jody M Ehrhardt is a certified clinical research coordinator with over 20 years of experience in the clinical research industry. Throughout her career she has worked in phase I-IV human trials as a clinical research coordinator, data coordinator, project manager, and Director of Research Services. She also consults for a major animal pharmaceutical company as a regulatory and development specialist. In 2012 she used the experience she gained from working in numerous roles, therapies and industries and founded her own clinical research facility.

Abstract:

According to Tufts CSDD, two-thirds of investigative sites fail to meet the patient enrollment requirements for a given clinical trial. And, whereas in 2001 nearly half of all patients screened for clinical trials completed them, in 2010 less than one in four screened patients were retained for the duration of the clinical trial. In light of this decline more sponsors are shifting their investigator recruitment focus to sites with proven patient recruitment and retention plans. If a clinical research site plans to grow and stay relevant a change in patient recruitment and retention planning that is aligned to how patients receive information and feel about clinical trials in mandatory. Successful research sites need to create and implement a strategy that combines social media, technology, subject needs and wants, and open communication while maintaining medical and protocol requirements. A successful strategy must also include every member of the research team in order to reach maximum effectiveness. And, site staff must realize that an integral member of this team is the trial volunteer.

Biography:

Tamera Norton Smith has twenty-six years of experience investigating and auditing severe GCP noncompliance. She began her career in GCP and GMP environments in 1990 with the USFDA's Atlanta and Buffalo Districts. Her passion for FDA's mission led her to found her own business in 1999 to audit independently and teach responsible research conduct and ethical research practices. She founded Norton Audits in 1999. It was founded on the sole principle that research participants and patients should be safe and protected while vital and effective products are investigated with complete and accurate results and outcomes.

Abstract:

Clinical research misconduct and fraud continues to impact solid research efforts and increases human research participate risks while participating in vital research efforts. Clinical research professionals need a scientific and valid approach to investigating reports of scientific and medical misconduct and fraud. Join with us as we present the ethical code of conduct for identifying, investigating, resolving and reporting of misconduct and fraud occurrences. The instructor has twenty-six years of experience investigating and auditing misconduct and fraud cases. Case studies will be used to demonstrated time proven skills and techniques for the prevention of misconduct.

Biography:

Jennifer Miller currently serves as President of Bioethics International, a nonprofit organization focused on the ethics, trustworthiness and governance of healthcare innovation, focusing on how medicines, vaccines and health technologies are researched, developed, marketed, and made globally accessible. She was previously a fellow in Harvard University’s Edmond J Safra Center for Ethics from 2012-2015. She also taught at Duke University, Fordham University and Columbia University. She holds a BS from Fordham University, a Doctorate in Bioethics from the Pontifical System, a Post-doctorate in institutional corruption from Harvard University, and completed a fellowship in regulatory governance at Duke University.

Abstract:

The Good Pharma Scorecard is a reform strategy that ranks new medicines, biologics and devices and their manufacturers on key integrity indicators, beginning with clinical trial transparency. The pilot index, published in 2015, ranks the transparency of all new medicines and vaccines approved by the FDA in 2012 that were manufactured by the 20 largest companies-342 clinical trials involving 99,599 research subjects. We reviewed these trials, drugs and companies on two sets of standards: 1. The ethical standard that all clinical trials and trial results should be publicly accessible, and 2. The legal standards for trial transparency enshrined in the US Food and Drug Amendments Act (FDAAA). We considered trial information publicly accessible if the trial was registered, reported results in a trial registry, was published in the medical literature and complied with transparency laws. Up until this point, transparency practices have never before been aggregated on the drug level nor assessed by both ethics and legal standards. We found that public disclosures of clinical trial information vary widely by company. Two companies publicly disclosed all of their clinical trial results and fully complied with legal requirements, for at least one of their drugs approved in 2012. While another disclosed only 20% of trial results and scored 0% on the legal compliance index. Today, trial disclosures for new drugs fall below legal and ethics standards with wide variation in practices among drugs and their sponsors. The GPS has the potential to improve compliance with legal and ethics standards and to support data-driven decision-making.

Biography:

Jill McNair has worked in the non-profit sector for over 20 years. She is the Senior Director, Patient Engagement at The Center for Information and Study on Clinical Research Participation (CISCRP). In this role, she oversees a team dedicated to helping sponsor companies provide lay language summaries to study volunteers. She also manages the planning, creation, and execution of CISCRP education and outreach programs; development and fundraising; marketing and public relations; and business development. She is passionate about providing education to the public so they can make an informed decision as to whether clinical research is right for them. Working at CISCRP affords her the opportunity to engage patients in the continuum of the clinical research process; whether it’s providing education when they are in a physician’s office or receiving a lay summary after they have given the gift of participation by participating in a study.

Abstract:

Studies consistently show that most clinical trial participants want to know what the research communities learned from their participation, yet most never hear from the sponsor or research site staff at all after a clinical trial has concluded. CISCRP has developed and tested a program to provide study volunteers with the results of their clinical trial. Working through our editorial panel of medical and health communications experts as well as patient advocates, CISCRP “translates” the technical results of clinical trials into scientifically accurate, non-promotional lay summaries written at a validated 6th-8th grade reading level. Prepared in printed, electronic and audio formats to accommodate different learning styles, the summaries are disseminated to volunteers via their investigative site as a way to fulfill researchers’ ethical obligation to return trial results, and demonstrate to volunteers that they are respected as true partners in the clinical research process. This presentation will focus on establishing a standard practice to communicate trial results to study volunteers. We will explore the following:

• How lay language summaries fulfill the ethical obligation to return trial results to participants
• Properly translate study results within lay summaries to ensure accurate return of results
• Establish the need for multiple communication methods to return results
• Develop a standard practice for communicating lay language

Biography:

Abstract:

This presentation concerns a new field covered by low temperature plasmas at atmospheric pressure for medical treatments. This is based on the very attractive possibility to tune and design plasmas as possible pharmaceutical products by using selectively some active species (charged particles, radicals, atomic and molecular agents, UV radiations) and even electric fields self-generated by the plasma. The delivery of active species occurs at the gaseous level. This means that there is no need for a carrier medium and the treatment of living tissue or surface is optimal because plasmas can penetrate small pores, spread over rough surfaces and reach both prokaryotic and eukaryotic cells. The present presentation gives first a review on the main low temperature plasma setups potentially usable for medical treatments with an emphasis on the setups as for instance plasma jets developed in our laboratory. Then, the presentation gives a review of the current state of the art of such plasmas as pharmaceutics products or therapeutic tools in Medicine with a light on a selection of forefront researches particularly in the field of cancer treatment using plasma activated media.

Biography:

Abstract:

Corticotropin releasing factor (CRF) signaling in the posterior ventral tegmental area (pVTA) mediates stress-induced psychostimulant self-administration. Recently, using a Cre-dependent tract-tracing approach with AAV-Flex-ChR2 in adult CRF-Cre male mice, we localized the source of pVTA-CRF to neurons projecting from the lateral hypothalamus (LH) and dorsal raphe nucleus (DRN) synapsing in the paranigral (PN) and parainterfascicular (PIF) sub-nuclei of the ventral posterior medial (VPM) sub-region of the pVTA. We observed that the DRN-, but not the LH-, VPM-CRF circuit was activated after repeated, but not acute, social defeat stress. Furthermore, we found that repeated optical or chemo-genetic activation of CRF in the VPM was sufficient to engender amphetamine (AMPH)-induced-locomotor behavioral cross-sensitization and escalated cocaine intake. Specifically, we observed that male mice with a history of repeated CRF optical or DREADD stimulation in the VPM displayed a significant increase in distance traveled in an open field test after treatment with a low dose of AMPH (1.5 mg./kg.) compared to saline treated and Cre-/- littermate controls. Subsequent cocaine self-administration experiments demonstrated that repeated DREADD CRF activation in the VPM enhanced drug-seeking behavior. Here we build upon these data by focusing on the DRN-VPM CRF microcircuit by using a combination of techniques. Previously, we observed site-specific increases in CRF-ir in the PN/PIF but not the parabrachial pigmented area of the pVTA following stress. Thus, we bilaterally infused CRF-Cre male mice with the G(q) DREADD virus into the DRN and implanted a unilateral microdialysis probe aimed at the PN/PIF and sampled the VPM for CRF during saline and CNO treatment. Our data demonstrate enhanced CRF release in the VPM of DREADD G(q) infected DRN-CRF neurons, after i.p. CNO injection. These results suggest functional increases in released CRF in the VPM after activation of DRN-CRF neurons projecting to the pVTA. We will extend this work by measuring dopamine (DA) release in the nucleus accumbens shell of mice with a history of DRN-VPM CRF microcircuit activity. These latter experiments aim to ascertain mesocorticolimbic CRF-DA interactions and potential increases in rate of cocaine self-administration and reinstatement after abstinence. At present, our data reveal a site-specific CRF microcircuit exclusively projecting from the DRN to the VPM sub-region of the pVTA, its sensitivity to social defeat stress, and VPM-CRF release presumably altering DAergic output in the forebrain after repeated experiences with brief episodes of social stress.

This research was supported by an NIMH R01 research grant NS073574 to J.M., a NIDA grant 031734 to K.M., the Tufts Center for Neuroscience Research grant P30 NS047243, and a Tufts Collaborates grant. The authors declare no biomedical, financial, or potential conflicts of interest. The experiments were approved by the Institutional Animal Care and Use Committee and were conducted in accordance with the National Institutes of Health Guide for the Care and Use of Laboratory Animals.

Biography:

Anvita Karara is a Life Science Professional with expertise in Clinical Trial Design and modeling. She pursued her Masters in Biotechnology and Management from Carnegie Mellon University, USA. She has worked prior in this space with leading bio-pharmaceutical companies such as Genentech (a Roche company) and Onyx Pharmaceutical (an Amgen subsidiary).

Abstract:

The bio-pharmaceutical industry is struggling to optimize the clinical development process and generate a sufficient return on investment. The critical factors that are challenging the operating landscape include: high protocol complexity, long clinical cycle time, rise in development cost and silo-based operating models. These challenges make it difficult to achieve enrollment targets, leading to protocol amendments and rework on the clinical development plan (CDP). Currently the pharmaceutical industry contains fragmented operating models based only on study level enrollment predictions. There is a need to re-engineer these silo-based study level operating models and create an integrated CDP operating model. This integrated program level operating model will capture all CDP scenarios, draft launch labels, target product profiles and estimated cost in a central location. It will enable higher cross-functional collaboration, planning and execution. It also helps the clinical development teams analyze multiple program level scenarios to determine the risk, cost and time tradeoffs. The integrated CDP operating model methodology signifies an innovative approach to re-engineering the current clinical development process. Combining the siloed study level enrollment predictions, enables the business to compare program level scenarios for better decision making. This approach can be an asset for high level clinical planning, boost efficiency, reduce trial spend and serve as a collaborative operating model.

Biography:

Ankit Lodha has high-end expertise in study conduct and interpretation of clinical operations data in the pharmaceutical/ biotechnology industry. He is Analytics Operations Lead in Clinical Application & Analytical Services (CAAS) at Amgen. Within Amgen he has worked on R&D and Commercial Analytics. Before this position he has provided strategic consulting services, supporting the analytics, data reporting and data management needs of senior leadership at AstraZeneca and Pfizer. He holds a Bachelors’ in Biotechnology Engineering from Dr. D.Y. Patil University, Masters in Business of Bioscience from Keck Graduate Institute and MBA from Redlands University – School of Business.

Abstract:

Pharma companies spend millions of dollars on research and even more on these clinical trials to ensure safety and efficacy of the drugs. Developing the right protocols, selecting the proper sites, setting the right expectations with all stakeholders, developing and tracking the right metrics and effective communication is the key to optimizing the resources and cost of clinical trials. The number of clinical trials underway each year has been increasing steadily, worldwide. In the last five years alone, over 75,000 federally and privately supported trials have been registered with the National Institute of Health’s Clinical Trials registry. Conducting clinical trials today is a complex set of activities that amass huge volumes of data from multiple systems. Having real-time clinical metrics and dashboards which provides insights on patient enrollment, study conduct, close-out and reporting is one of the biggest challenges for bio-pharmaceutical R&D industry. With a broad range of study designs, varying data collection methods and time points, efficient data analysis in clinical development has become more important than ever. The more effectively study data are managed, the faster the data can be extracted and analyzed. The analysis of the data is important for each trial stage as valuable insights can be gained. For example, during the early stages of a clinical trial, access to data is vital not only for patient safety, but for solving problems while they are still manageable and before they become costly.

Biography:

Suzanne Bishop is the North American Facilitator for the eClinical Forum, a non-profit global discussion and action group representing members of the pharmaceutical, biotechnology, and allied industries focusing on electronic capture, handling, and submission of clinical data. Recent projects have focused on Electronic Health Records for Clinical Research. She was the project manager of the EHRCR project which resulted in an HL7 and ANSI Standard Functional Profile and a EuroRec-approved profile, and the eSource Readiness Assessment (eSRA) tool. Suzanne holds an MA in Organizational Leadership and a BS in Computer Science and has worked for the past 30 years in the area of software application support for clinical research.

Abstract:

The eClinical Forum – a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and Clinical Research Services industry, have developed a regulatory-based assessment tool for EHR vendors or sites to determine if their EHR system is appropriate to hold regulated clinical trial data. This tool will help make the clinical research process more efficient, while furthering the use of EHR records for clinical research. It is offered free; there are no advertisements on the website and your information will not be used for other purposes. The eClinical Forum’s only intent is to make the process more efficient for everyone. Through the use of the eSource Readiness Assessment Tool (eSRA), EHR vendors can provide information to their customers who do clinical research, to help these clinical research sites determine if they are meeting regulations. The clinical research sites are already being asked these questions by their clinical research sponsors (pharmaceutical companies) and it can be timely to complete a different form for each research sponsor. By using the eClinical Forum tool, the site can complete just one assessment and give it to each of their sponsors. We have already shown this tool to regulators and had a favorable response – some are even presenting it at industry conferences. The more EHR vendors that participate, the easier it is for their sites to participate, and the more sites that participate, the easier it is for their sponsors to participate. If everyone uses this assessment form then it really does become a highly efficient way to gather the information that regulators want – information that shows that the systems that may originate data that could end up in a clinical trial has integrity.