PharmaNet’s Global Data Management team comprises dedicated professionals with experience and expertise across a broad spectrum of therapeutic areas. These professionals include physicians, LPNs, RNs, validation specialists, medical laboratory technologists, clinical-site coordinators, and technology experts. Software and software-support professionals are also available through PharmaSoft®, the Information Technology solution from PharmaNet.

 

Custom-Tailored Solutions

Global Data Management professionals work in concert with sponsor teams to develop an up-front strategy for managing project data, with stringent quality-control measures applied at every step. The result is an efficient process for collecting and organizing data. PharmaNet then works with sponsors to select the most appropriate tools and technologies to capture, store, clean, and analyze project data and to ensure compliance with 21 CFR Part 11 regulations. Systems utilized by PharmaNet include Oracle Clinical™ and SAS®. In addition, PharmaNet employs an array of PharmaSoft solutions, including programs for:

 

Electronic and facsimile data capture

Clinical data management

Project management

Interactive drug management and supply

Adverse event management

Dictionary coding

Laboratory data management

 

A Global Network of Resources

PharmaNet conducts Phase I–IV programs globally, with offices around the world and 6 dedicated data management centers in the US, UK, and India. These centers follow one set of standard operating procedures to ensure global consistency, enable optimal workflow through resource management, and provide efficient processes that address local cultural differences.

 

PharmaNet’s Global Data Management team includes professionals who are experienced with the data-reporting requirements of worldwide regulatory authorities. These professionals can help you create regulatory-friendly scientific databases for reporting and analyzing all phases of product development.

 

Data Management Services

PharmaNet offers a comprehensive range of data management services for studies conducted by both electronic and traditional paper methods. These services include:

 

Consultation on strategies, systems, databases, procedures, and metrics
Case Report Form design
CDISC compliance
Database design, validation, and implementation
Data capture via keyboard entry, fax, and EDC
Data validation, review, and cleaning
	Medical coding using both standard dictionaries, such as MedDRA and WHO-DD, and proprietary, sponsor dictionaries
	Safety procedures, including SAE reconciliation and the management of protocol violations, deviations, and endpoints
	Quality Control (QC) to high standards, with QC processes at each step to ensure high-quality deliverables
Data consolidation, migration, and conversion
	Management of data from third-party vendors, with automated transfers between external systems

 

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Jeanne Ashton, MS Vice President, Data Management Ms. Ashton has more than 26 years of industry experience, including the last 10 years at PharmaNet. Previously, she spent 16 years at a major pharmaceutical company, where she focused on Data Management Operations as well as selection, validation and implementation of clinical systems. Ms. Ashton has significant experience in the management of EDC trials and the development and implementation of the systems and processes to support them, including implementation of both Clintrial and Oracle Clinical. She has managed programs in many therapeutic areas, in all phases of clinical development.

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Suresh K. Bowalekar Executive Director, PharmaNet, India Dr. Bowalekar has more than 30 years of experience in statistics and clinical trial management. Prior to joining PharmaNet in 2003, he was Director, Data Management and Biostatistics for Quintiles. Dr. Bowalekar was also General Manager, Clinical Research and Statistics at Wockhardt Limited and was a Clinical Trials Manager for Searle Limited, both in Mumbai. He is the author of books on both statistical analysis and operations research, and has published more than 60 research papers and 100 presentations.

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Chris Cramer Senior Director, Data Management, Europe Ms. Cramer has more than 20 years of experience in both the pharmaceutical and CRO industries. She began her career as a research microbiologist, and has worked the past 12 years in data management. Ms. Cramer has served as project manager for multi-service clinical trials and has managed clinical data from a wide range of therapeutic areas including transplantation, oncology, diabetes, hypertension, and Crohn's disease.

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Jack W. Green, PhD Senior Vice President, Biostatistics and Data Management Dr. Green has held senior-level positions for more than 25 years in both the pharmaceutical and CRO industries. He previously was Senior Biostatistician at Merrell-National Labs, Director of Biostatistics at Adria Laboratories, and Senior Vice President of Biostatistics and Data Management at a CRO.