WHO WE ARE
Waife & Associates, Inc. staff have direct experience in clinical trial operations, process improvement analysis and implementation, and two decades of cross-company observation and learnings. We apply these in pragmatic, cost-effective projects that produce greater organizational efficiency and effectiveness for our clients.
Ronald S. Waife, MPHPresident"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.
Steve Shevel, MBASenior Associate““Everyone is talking about RBM, but not everyone knows how to operationalize it correctly and pragmatically. We do.””
Steve Shevel, Senior Associate, has been with Waife & Associates, Inc. since 2008. He has over twenty years of experience in all phases of clinical study team operations. Beginning as a CRA with Quintiles and then as Senior CRA at Eli Lilly, Mr. Shevel worked in a dozen therapeutic areas, including CNS, oncology, diabetes, ophthalmology and medical devices. Steve then worked as a Clinical Operations Manager and study team leader at Pfizer, AstraZeneca, GlaxoSmithKline and Allergan.
When Mr. Shevel joined W&A from Allergan, he was Associate Director of eSolutions, a role in which he was responsible for leading assistance to the company's clinical study teams in transitioning to full use of EDC, ePRO, IVRS and CTMS technologies.
Besides providing representation for W&A on the West Coast, Mr. Shevel provides its clients particular expertise in eTMFs, CRO management, ePRO (electronic patient-reported outcomes) study implementations, IxRS, eClinical vendor management, and assistance with eClinical study team transitions.
Mr. Shevel earned his undergraduate degree in microbiology and genetic engineering at UC Santa Barbara, and his MBA from UC Irvine. He staffs the W&A office in Southern California.
Detlef Nehrdich, MSSenior Associate“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.
Ramzi NajmSenior Associate“Biopharmas and CROs have realized they have a disconnect between their clinical research software and the continuing use of paper-based or poorly computerized Trial Master Files. This Achilles heel threatens efficient submission, compliance and trial oversight. We know how to tailor your diverse processes and the enabling tools to make true eTMFs that work.”
Ramzi Najm, Senior Associate, joined Waife & Associates, Inc. in 2015. He has over thirty years of experience in the biopharmaceutical industry, both in biopharmas and CROs, and his work experience has ranged from clinical data management to information technology and strategic innovation for clinical development. He served in senior roles at IBRD, Paragon, Concensys and Baxter Bioscience, before spending 14 years at Allergan. He compiled a strong track record of significantly raising the performance of organizations and delivering value through teams and individual contributions, through hands-on and energetic engagement.
When Mr. Najm joined W&A from Allergan, he was Vice President, Strategic Analysis and Process Innovation, a role in which he was responsible for providing strategic direction to various R&D business functions and services, including Resource Management, IT Portfolio and Planning oversight, Analytics and Metrics, and Performance Management.
Mr. Najm provides our clients particular expertise in process analysis, innovation implementation, CTMS’s, eTMF’s, CRO management, eClinical vendor management, and executive strategy consultation.
Mr. Najm earned his undergraduate degrees in biology and computer sciences at UC Irvine, and his MBA from Pacific States University. He is based in Southern California.
Eve-Marie Whitsun-JonesAssociate“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.
Joseph S. AndersonPrincipal Advisor“Vendor Oversight Management may be the most critical missing skill in biopharma today. We know how to help clients with practical improvement in this area.”
Joseph S. Anderson, Principal Associate, focuses on the issues surrounding vnedor oversight management, technology choice and implementation, and a special expertise in change management, the financial analysis of clinical research software adoption and process change. Mr. Anderson also leads our drug safety operations optimization practice. Mr. Anderson has over 25 years experience in the pharmaceutical industry, including nine years consulting to European and U.S. pharmaceutical companies while living in Germany. He joined Waife & Associates in 1998.
Mr. Anderson has done groundbreaking work in the area of clinical research metrics. He has developed sustainable metrics programs for various clients that measure both costs and productivity in the conduct of clinical trials. He has also developed cost/benefit and ROI models for enterprise software acquisition at multinational biopharmas.
Mr. Anderson has worked on multiple NDA and EU submissions, participating in the planning and execution of SAS programming for CSRs and integrated safety summary reporting. He 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.
Previously Mr. Anderson was a Project Manager at Technilogix, Inc., a second generation EDC provider. Before that, he spent five years with Eli Lilly and Company, designing various clinical data systems to support all aspects of the clinical trial process. In addition, Mr. Anderson worked at the Lilly German affiliate, where he was European project manager for the design and implementation of a worldwide electronic data capture system.
Mr. Anderson has a B.S. in computer science and mathematics from Grand Valley State University in Allendale, Michigan. Mr. Anderson has contributed to various industry publications and is a frequent presenter at industry meetings. He is currently co-Chair of the SCDM. He is fluent in German and staffs our Research Triangle Park, NC office.