"We are proud of our 20+ years record of helping biopharma companies find efficiency in their operations. Our innovative consulting provides pragmatic strategies that are customer-specific and immediately operational. We are completely independent from any other service providers, software or parent company interests. We are known for telling the truth to our clients, and for the judgment that comes from senior domain expertise."

Ronald S. Waife is President, Waife & Associates, Inc., a change management consultancy focusing on clinical research in the pharmaceutical industry. Since 1993, Waife & Associates has been helping health care companies build competitive advantage through process improvement and technology. The company has served over two hundred clients, including biopharmaceutical research sponsors, CROs, AROs, technology vendors and investors. Services include clinical operations and drug safety process improvement, technology strategy, Organizational Preparedness™ for technology and process implementation, virtual executive services in clinical operations and CDM, vendor selection and implementation management, general management of application development projects, and investor advising.

Mr. Waife is also Executive Director of The Clinical Research Executive Forum®, a seminar series for industry executives exploring how to improve the clinical research process. He has been Chair of the Editorial Board of the Association of Clinical Research Professionals (ACRP), the first Chair of its Technology Forum, and writes a bimonthly column for their Monitor. He also wrote a regular column on process improvement for Applied Clinical Trials.

Mr. Waife's previous experience includes a decade of executive positions in high technology, and a decade in international public health. Mr. Waife has also been an instructor and facilitator in Total Quality Management (TQM) techniques, and is a frequent lecturer at international conferences.

Mr. Waife is listed in the PharmaVOICE 100 for 2008, and received The Meritorious Service Award from the ACRP in 2006. He previously won numerous awards for medical education filmmaking.

Mr. Waife received his undergraduate degree in social and behavioral sciences from The Johns Hopkins University, and his masters in public health from Harvard.

“Clinical Data Management remains the lifeblood of product approval. New technologies, techniques and business imperatives continue to expose those whose CDM operations are inefficient or inadequate. We help fix these mission-critical deficiencies.”

Detlef Nehrdich, Senior Associate, joined Waife & Associates in April 2012 after twenty years in the biopharmaceutical industry. His particular areas of expertise include process improvement, metrics and data management, in addition to his professional background as a biostatistician. As a senior manager in industry, his leadership positions provided extensive experience in personnel management and acquisitions integration. Mr. Nehrdich also worked in technology planning, vendor evaluation and the organizational implementation of new technologies and processes.

Previously Mr. Nehrdich has been Site Head, Statistics & Data Management, and Global Director of EDC Operations, at Abbott Laboratories in Ludwigshafen, Germany. In this position Mr. Nehrdich led Abbott's Statistics and DM activities in Europe and was globally responsible for Abbott's eClinical activities. Mr. Nehrdich successfully managed Abbott’s project for the global preparation and implementation of EDC in 2006. In 2009 he initiated a cross-functional project for global ePRO implementation, and in 2010 worked directly on the integration of Solvay.

Prior to Abbott, Mr. Nehrdich worked as Biostatistician and later Head of Data Management in the Biometrics Department of Viatris (previously ASTA Medica) in Frankfurt, Germany.

Mr. Nehrdich has been very active in DIA Europe, serving on the Program Committee, as session chair, and speaker at all previous DIA Clinical Forums. He has spoken at the DIA Annual Meeting and served as session chair at the DIA EuroMeeting. Mr. Nehrdich has been a core team member of the Clinical Data Management SIAC and has served on the DIA Advisory Council for Europe. He has published more than a dozen papers in scientific journals since 1995.

Mr. Nehrdich earned his MSc in Statistics from the University of Dortmund, Germany. He is fluent in German and English.

“The EDC revolution is far from over. Many biopharmas have simply put a veneer on their paper processes. Optimizing the potential benefits of eTechnologies requires continuing effort, which we are uniquely suited to assist.”

Eve-Marie Whitsun-Jones, Associate, has been with Waife & Associates since 2004. She has a diverse background in clinical project management, postmarketing research, regulatory systems, and clinical finance, with additional experience in managing EDC implementation from the clinical operations perspective. At W&A, she has worked on one of the largest cardiovascular postmarketing trials, has led EDC and eTMF implementations, worked on safety surveillance optimization, and various audit and training services. Before joining Waife & Associates, Ms. Whitsun-Jones spent twelve years at Pfizer, where she was active in eSubmissions, finance systems, implementation of ASP-based EDC, and clinical operations.

She and other W&A staff have also managed projects that extract, transpose and deliver study-level data into Clinical Data Warehouses for inclusion into statistical programming efforts and submission of new product registrations. She and other W&A staff have direct experience in the use of typical CDW tools such as SAS Drug Discovery and JReview, and is also familiar with ODM and SDTM data models and their downstream use by statisticians, either as SDTM or ADaM data sets.

In a series of management positions at Pfizer, her experience included managing the development and implementation of a system to track regulatory events & activities as they related to submissions to Health Canada, managed the development and implementation of a CTMS to track and Canadian clinical and financial R&D activity for Phase 3b-4 trials, and developed a clinical supplies management system which ensured GMP-compliant tracking and inventory management. Ms. Whitsun-Jones was a representative on the APETI (Advisory Panel on the Electronic Transfer of Information).

She received her undergraduate degree in Biology from McGill University. She is fluent in French and staffs our Montreal office.