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Both companies were founded more than a decade ago to address high failure rates of clinical trials of psychotropic drugs, the efficacy of which are measured with subjective ratings susceptible to biases, variability and error. MedAvante pioneered Central Ratings, an unconventional solution built on the novel idea of having a small highly calibrated cohort of expert raters administer clinical outcome assessments remotely. ProPhase became a global provider of measurement-related specialty solutions in clinical trials by focusing on optimizing the selection, use, and analysis of behavioral endpoints to mitigate trial risk and maximize the likelihood of study success.
As Central Ratings gained acceptance in large global studies, MedAvante replaced the paper-based rating scales its own clinicians were using by developing a digital platform to administer clinical outcome assessments eCOA and manage electronic source eSource data, starting in MedAvante-ProPhase is committed to continuing to bring digital innovation and scientific quality to the crucially important process of collecting, managing and analyzing clinical trial data.
Litwin was named to his current position in April Before assuming his current role, Dr. Litwin was President of Litwin Consulting LLC and he also co-developed and launched Patient Genesis, an innovative software platform used by health care providers to create, share and transfer knowledge to patients during the informed consent process.
For more than 14 years, Dr. He served for more than three years as CEO of ERT, leading the then public company in a private equity acquisition via leveraged buyout in Earlier in his career, Dr. Litwin earned his M. Steve Herne, an experienced sales and business development executive in both technology and services, joined MedAvante-Prophase as Chief Commercial Officer in July with overall responsibility for sales and marketing.
Prior to his appointment, he was Chief Commercial Officer, eHealth Solutions at Bioclinica, a provider of clinical trial management solutions. Herne began his career as a Senior Research Scientist for Inveresk Research before moving to a business development position at Quintiles and then returned to Inveresk as Senior Business Development Manager. In that position, he led the planning and implementation of a finance reorganization process.
Downing also lent support to responsibility, strategy, capital investment, expansion and financial training. In addition, he led a team responsible for the overall financial health of projects, including profitability, revenue recognition, cash flow, invoicing, and financial training for project managers and their teams.
Before joining Covance, Mr. Greg Barrett leads worldwide software and platform development for MedAvante-ProPhase, supporting clinical science and signal detection capabilities. He joined the company in April , bringing 30 years of information technology experience. In his role as Global IT Leader for Covance, he oversaw team members supporting five business units with applications, architecture, business engagement and computer systems validation.
As Vice President of Regulatory and Quality Assurance since she has been responsible for evaluating activities of regulatory significance and ensuring that quality standards and regulatory requirements are implemented and maintained throughout the organization while leading audit teams in successful completion of more than 60 customer audits without a single significant finding.
Widely recognized for her achievements in organizational leadership, Ms. Wilmer is often sought for advice and collaboration and asked to share her expertise with professionals worldwide through networking and consulting. Wilmer worked for more than 20 years in health care where she developed expertise in regulation interpretation. At Horizon Blue Cross Blue Shield of New Jersey, she successfully developed and managed health care policies and administrative procedures to ensure compliance with regulatory agencies and other standards for a network of over 10, providers.
She has developed recruitment, contracting, and retention strategies for employees, physicians, and ancillary providers. He also has a strong background and interest in psychometrics and neurocognitive assessment, having worked for over 20 years as a consultant on test development, including the revisions of the Wechsler intelligence and memory scales.
Randolph is Clinical Professor of Neurology and Director of the Neuropsychology service at Loyola University Medical Center and is board-certified in clinical neuropsychology. Before joining MedAvante-ProPhase in July , he held the position External Clinical Innovation Leader at Roche, where he was responsible for developing, integrating and operationalizing strategic innovations throughout drug development.
Prior to that post, he was Vice President, Project Management, Americas for the clinical research organization PRA HealthSciences, leading a team of clinical research professionals covering all therapeutic areas. He also held senior project management and operations posts at Worldwide Clinical Trials, Inc.
Cioffi holds the B. Detke is a psychiatrist with more than 20 years of research experience and extensive clinical and drug development expertise. This role included registration and regulatory commitment trials for Cymbalta, including major depressive disorder, diabetic peripheral neuropathic pain, generalized anxiety disorder, fibromyalgia and chronic pain, as well as pediatric trials. Detke teaches and supervises medical students and residents as Clinical Professor of Psychiatry at Indiana University School of Medicine.
He trained in medicine and psychiatry at Harvard Medical School and at the Mt. Detke has published more than 60 manuscripts in peer-reviewed journals since Williams has more than 30 years of clinical research experience in both industry and academia. She is now Professor Emerita at Columbia University. Williams is well known in the field for her development of psychiatric classifications and instruments to measure psychopathology.
She is the author of more than scholarly publications and serves on the editorial boards of several psychiatric and social work journals. She has received numerous awards for her achievements and contributions in social work and psychiatry.
His research groups also led development programs for the analgesic drug tapentadol, the long-acting antipsychotic agent paliperidone palmitate, and other potential treatments for CNS disorders. Kobak is a psychologist with more than 30 years of clinical research experience in both industry and university medical settings. Throughout his career, he has focused on clinical assessment, rater training, rating scale development and clinical trials methodology. Kobak founded the consultancy Research Training Associates, where he developed new methodologies for training and calibrating raters in clinical trials using digital technologies.
Kobak managed a clinical trials unit and pioneered the use of computer-administered rating scales in clinical trials. He authored computer-administered versions of several clinician-administered rating scales, including depression and anxiety scales that are widely used today, and a computer-administered version of the PRIME-MD, a diagnostic interview that was published in JAMA.
Kobak received several NIMH grants to develop and study rater training methodology for depression, schizophrenia, and autism. Negash serves as the scientific lead bridging research and operations to ensure MedAvante-ProPhase clinical trial services are implemented successfully from a scientific and service delivery perspective.
Her work has focused on investigating factors associated with successful cognitive aging, including lifestyle factors such as cognitive activity, and on developing interventions that enhance cognitive fitness in older adults.
She also studies successful cognitive aging in minority populations, particularly African-Americans. Her other area of work focuses on examining implicit and explicit learning and memory systems in healthy aging and in mild cognitive impairment. Kane has been the principal investigator for research projects focusing on schizophrenia, psychobiolgy and treatment, recovery, and improving quality and cost of care. He is the author of over peer-reviewed papers and serves on the editorial boards of numerous journals.
Sue Vallow is a patient-reported outcomes PRO scientist with more than 20 years of experience developing and implementing patient-focused outcomes strategies and capabilities in numerous therapeutic areas with a specialty in CNS trials. She is a co-author of more than 20 peer-reviewed papers and more than 70 research posters and presentations. Sofija Jovic is focused on the strategic combination of MedAvante-ProPhase as the thought leader in using measurement science and data quality to transform clinical trials.
Jovic guided the transformation from a four-person start-up to a global industry leader in collaboration with ProPhase founder Dr. Jovic started her career as a clinical psychologist: Jovic has published in peer-reviewed journals and presented scientific papers at professional and industry conferences. His academic research focuses on the etiology, phenomenology, and treatment of serious and persistent mental disorders.
He has co-authored over 40 peer-reviewed publications and has contributed to multiple book chapters and review articles on schizophrenia and mental health research. Lord-Bessen oversees MedAvante-ProPhase Clinical Data Analytics services including data management, statistics, and psychometric activities, including consultation on the development and validation of new Clinician-Reported and Patient-Reported Outcomes as well as the conversion of existing assessments to electronic format.
Lord-Bessen has over twenty years of experience in statistics and measurement. Twelve board members from leading universities and research institutions provide counsel and guidance to MedAvante-ProPhase on initiatives relating to mood, anxiety, schizophrenia, and other psychiatric disorders.
Co-chaired by John M. Richard Feinberg Chair in Schizophrenia Research. Eleven top leaders from major Japanese universities and research institutions provide their expertise to enhance the ability to collect high-quality research data with less error and greater signal detection.
At MedAvante-ProPhase, we look for colleagues who combine talent with a powerful desire to change healthcare for the better and ensure that effective therapies make it to the patients who need them. This is the mission uniting the clinicians, scientists, technologists, and operations experts whose mix of energy, inventiveness, and skill drives not only MedAvante-ProPhase but the entire WIRB-Copernicus Group family of companies in a relentless quest to improve clinical trials.
What do you do at MedAvante-ProPhase? As a member of the Business Development team, I am responsible for overseeing the creation of our responses to requests for information and proposals from drug development sponsors planning clinical trials. I also serve as a subject matter expert on clinical and technical aspects of our service solutions.
Why did you decide to work at MedAvante-ProPhase? What do you like best about your job? MedAvante-ProPhase lacks the layers of hierarchy that can kill good ideas or contributions from different departments, and our entire team is determined to stay on the forefront of signal detection and clinical trial technology.
What are your colleagues like? Hard working, open and approachable. They like to be challenged, and they constantly push the limits of their comfort zone to ensure that quality of service is the first thing any customer remembers. What impact has working at MedAvante-ProPhase had on you? My job is to perform live clinical psychiatric interviews by phone and video conferencing with study subjects participating in clinical trials. I also review documents and recordings of neuropsychological and psychiatric assessments conducted by other clinicians to provide feedback on scoring and administration.
I found in MedAvante-ProPhase a great place to use my behavioral health experience in a clinical trials setting, as well as a perfect fit for my years of face-to-face counseling, neuropsychological assessments, and phone work at an employee assistance program provider. I like the excellent training, as well as the opportunity to work with a dedicated group of professionals.
I have worked a number of places in my career before MedAvante-ProPhase but I never met a more caring and dedicated group of employees as I have here. While I work in the office, I feel just as connected to my peers who work remotely. The learning at MedAvante-ProPhase for me started on day one, and has never stopped.
As the company grows, so does my ability to gain further skills as a clinician and professional in different research areas.
I administer the adjudication process for large global studies by tracking cases, contacting sites for needed information, and assembling and storing the required documentation. I come from the medical field, having graduated as a Medical Doctor in Dominican Republic.
I really love the flexibility that makes my work very convenient for me and my family. I also like the way our multicultural team all treats each other with respect and I enjoy working with colleagues from around the world.