Senior Management
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Nancy A. Kohl
PresidentNancy Kohl, President - Ms. Kohl has over thirty years experience in pharmaceutical industry with specialization in Clinical Operations, Data Management and Reporting. She has been a presenter at DIA, ACRP and CDISC meetings and seminars on Quality Management, Contracting Services and Data Operations. She taught Data Management and Clinical Monitoring courses at the post-graduate level at Villanova University.
Ms. Kohl is a graduate of the University of Pennsylvania School Of Allied Medical Professions and also attended the Wharton School of Business. She launched her career in the Department of Orthopedics at the Hospital of the University of Pennsylvania. She joined the pharmaceutical industry in 1985 as a manager of worldwide data management and application programming at SmithKline Beecham, overseeing a significant number of projects and personnel, as well as corporate standards. In 1990 she accepted a clinical position in Sterling Drug’s Diagnostic Imaging division, contributing to several successful regulatory submissions. Her last corporate position was as Director at Centocor (division of J&J) where she was closely involved in a successful corporate FDA audit and three successful regulatory submissions.
Since launching QDS in 1995, she continues with the oversight of corporate growth and the business management of the company.
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Victoria M. Marino
Senior Director, Regulatory Operations and Scientific CommunicationsMs. Marino is currently Sr. Director, Operations and Scientific Communications, Quality Data Services, Inc. She has twenty years of experience in various positions within Clinical Research and Operations with biopharmaceutical companies. She has been a presenter at various meetings and seminars on Drug Development, GCPs, and Clinical Study Management.
She graduated from Hartwick College with a BS in Medical Technology. After spending many years as a bench scientist in Hematology/Oncology, she joined the pharmaceutical industry in 1991 as a Phase 1 Site Manager. In 1995 she joined Centocor and held positions within Data Management, Quality Assurance, and Clinical Research. In 1997, she joined Astra-Merck as a Clinical Program Manager with oversight and management of Nexium NDA and sNDA work. She had held positions of increasing responsibility at the Covalent Group, Dermik Laboratories, and Shire Pharmaceuticals in Clinical Development and Commercialization prior to joining QDS in 2005.
Since joining QDS as Project Director, she now oversees Clinical Operations, which includes: Clinical Project Management, Regional Monitoring, Safety Management, Medical Writing and Biometric Operations of the company.
She has contributed to numerous successful NDA, PLA and SNDA submissions in her career.
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Monica Freese
Director of Project Management and PharmacovigilanceMs. Freese is currently Director of Project Management and Pharmacovigilance at Quality Data Services. She has had an impressive 15 years of experience in clinical development within the pharmaceutical industry. She graduated from Reading Hospital School of Nursing as a Registered Nurse and obtained her Bachelor’s degree from Eastern University. After working as an Oncology Nurse at Montgomery Hospital, she entered the pharmaceutical industry as a Clinical Research Associate in 1995 at Rhone Poulenc Rorer. In 2000, as a Clinical Trial Manager at Sanofi Synthelabo, she managed the primary studies that lead to the registration, approval and label extension for Oxaliplatin, including pediatric approval. Most recently, she headed the clinical and submission task force activities for the filing and approval of Jevtana. She has held various Clinical Research and Project Management positions and has performed a variety of activities, including pre-approval inspection preparation with great success.
Since joining QDS in 2011, she oversees the company’s Pharmacovigilance activities; management of select clinical trials; and corporate management of projects to meet QDS’ goals of a quality product delivered on time and within budget.
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Annette E. Inker
Senior Manager, Quality AssuranceMs. Inker is currently Senior Manager of the Quality Assurance Department for the Contract Research Organization of Quality Data Services, Inc. She has 25 years of experience in various departments as Medical Technologist and Quality Assurance Officer within the Clinical Lab division of SmithKline Beecham (now GlaxoSmithKline), followed by an additional 10 years of experience with QDS in Data Management and Quality Assurance.
She attended Temple University and performed her 2-year clinical rotation with Northeastern Hospital in Philadelphia, PA. She started at SmithKline Beecham as a Medical Technologist in Automated Chemistry, and continued performing in the departments of Endocrinology, Special Chemistry, Immunology and Virology, the last serving as Senior Medical Technologist and Quality Assurance Officer.
Since joining QDS in 2001 as Data Coordinator, she now oversees Quality Assurance activities, which include validation of project-specific database exports, quality control of clinical studies, writing and maintenance of Standard Operating Procedures, QDS' Training Program, and assisting with audits for and against the company.
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Lauren Kargher
Assistant Director, Clinical OperationsMs. Kargher has ten years experience in various positions within Clinical Operations.
Ms. Kargher graduated with a Bachelor of Science from the Northeastern University Bouve College of Health Sciences.
Ms. Kargher joined QDS in 2001 and has held positions in Clinical Data Management and Clinical Operations. She has experience with multiple therapeutic areas including CNS, Vaccine, Ophthalmology, Cardiovascular, Oncology and Phase I PK trials. Ms. Kargher has managed many trials from study start-up through completion and boasts and exceptional track record of key performance indicators and adherence to study budgets while maintaining her commitment to quality. She has presented management of study timelines and key performance indicators at state Biotechnology meetings.
In addition, Ms. Kargher led the successful development and implementation of the CTMS component of QDS’ e-clinical suite.
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Laura O'Donnell
Associate Director, Data OperationsMs. O'Donnell is currently the Assistant Director, Data Operations of the Contract Research Organization, Quality Data Services, Inc. A graduate of Juniata College, Laura has worked in various functions of data management at QDS since 2000.
Laura's therapeutic experience includes CNS (Psychiatric and Neurological), Oncology, Ophthalmology, Gastrointestinal, Dermatology, Cardiovascular, Allergy/Respiratory, Immunology, and Medical Devices. She has participated in domestic and global studies across all phases of clinical development.
Laura now oversees Clinical Data Management personnel, processes and procedures at QDS. Laura has been instrumental in the development of the QDS Electronic Data Capture application, QDRx, and in the implementation of data collection standardization, utilizing the CDISC platform.
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John Paige
Assistant Director, Information TechnologyMr. Paige is currently Assistant Director, Information Technology for Quality Data Services, Inc. For the past fifteen years, he has focused on implementation and management of IT solutions, specializing in Microsoft-based technologies, networks, and security.
A graduate from Penn State, Mr. Paige joined Intelligent Electronics in 1992, eventually becoming IT Systems Engineer for their subsidiary, XLConnect Solutions, Inc., providing network, server, and workstation support. XLConnect was acquired by Xerox in 1998, and he continued working for Xerox Global Services as Senior Systems Manager, managing a data center and IT support services for over 1000 employees before joining QDS in 2007.
In his role with QDS, Mr. Paige manages Information Technology, supporting QDS’ network and systems, and Clinical Information Services supporting the QDRx application.