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Clinical & Preclinical Systems Validation

Clinical research relies on accurate data and many companies are increasingly dependent on electronic data collection (EDC) systems to increase data accuracy, reduce query time and reduce the time it takes to close databases at the end of a trial.

From the development of e-case report forms to the input of data at the investigator sites, to query resolution, to the cleaning and coding of data, to the closing of the database, to statistical analysis, to submittal of the results, accurate regulatory compliant computer systems are absolutely essential.

Whether you are using in-house systems or relying on third parties to conduct and manage your clinical trials, it’s critically important to confirm the ability of the computer systems and processes to provide accurate, traceable data and to protect your valuable data from tampering, industrial espionage and/or accidental loss.

"PharmaSys understands the nuances of compliance and validation of clinical systems including EDC systems"

Additionally, pressure by regulatory agencies to prove that systems are compliant with reverent regulations including GCP’s and the electronic records/electronic signature rulings (21 CFR Part 11) make it mandatory for computer systems used in clinical trials have sufficient SOPs for operation and maintenance and be validated.

In the best case, if systems are not in compliance with regulations and current good practice (cGxPs), NDA or 510(k) submittals could be delayed costing the sponsor company millions of dollars in lost revenues. In the worst case, data may be erroneous or incomplete creating a situation where a new entity is erroneously discarded.

"PharmaSys is internationally recognized as experts in compliance and validation of clinical systems and data management facilities.”

PharmaSys has extensive experience with compliance issues for pre-clinical and clinical systems and is recognized as a world leader in clinical system compliance and validation. One of our founding officers successfully directed all IT operations for one of RTP's fastest growing clinical research organizations before forming PharmaSys. PharmaSys has provided compliance training, turn-key validation packages, audits, and validation support for companies located in the US, Europe and Asia.

"PharmaSys provides custom compliance and validation solutions to our customers. We do not provide “cookie-cutter” or “one size fits all” approaches. Of course we have an extensive database of test scripts for most applications but that’s only the starting point. Our real value is our ability to put together complete, defendable validation packages for clinical systems. The FDA expects a system to be validated for the way it’s being used and that’s what we provide.

Charles Lankford, CEO

Specific Clinical Systems Experience

Some of the systems that PharmaSys has experience with include:

• Clintrial™ - Clinical Data Management System (CDMS)
• Clintrace™ - Adverse Events System (AES)
• Oracle Clinical - Clinical Data Management System (CDMS)
• PhOSCo - (Formally IBM ClinWare) Electronic data capture system (EDC)
• PharmaTrace - Adverse Events System (AES)
• eData Entry™ (eDE) -Internet-based electronic data capture (EDC) system
• eData Management™ (eDM) - Internet-based clinical data management system

Clintrial™ and Clintrace™ are trademarks of Phase Forward, Inc.
eData Entry™ and eData Management™ are trademarks of eResearchTechnology, Inc. (eRT)

Capabilities

• Validation project management
• Turn-key systems validation projects
• Risk assessment of clinical systems
• 21CFR Part 11 assessment and remediation services (PharmaSys 21CFR Part 11 position statement)
• Development and execution of test scripts
• Validation compliance audits
• Quality audits of application services providers (ASPs)
• Quality audits of third party data management facilities
• Quality audits of third party data hosting facilities
• Computer systems supplier audits
• Infrastructure and network qualifications
• Clinical computer systems validation and compliance education (one, two and three day courses)

If you are interested in finding out more about PharmaSys' world-class offerings, complete and submit the form provided below. You will be contacted to discuss your needs and provided with information about how PharmaSys can help you achieve your compliance and validation goals.