Pharmaceuticals

PruTech’s experienced consultants work seamlessly with clients in the pharmaceutical, biotechnology, and medical device/diagnostic industries to resolve complex problems, implement the best practices, and continuously improve operational processes at critical junctures. We have tailored our services to assist our clients in meeting strategic business goals as well as in complying with regulatory standards. PruTech provides a full range of clinical services and resources to ensure expedited development and successful submission to regulatory agencies. We offer services ranging from single components, such as monitoring and data management, to fully integrated clinical development programs.

Our expert staff design, develop, and maintain quality systems and ensure the validity and accuracy of required data. We also assist our clients in complying with FDA regulations and guidelines.

Some of the solutions we provide to our pharmaceutical clients are as follows:

  • Data Management
    • Case report form design and production
    • Database and data entry screen design
    • Data Management and mining
    • Adverse event and medication coding (MedDRA, WHO DRUG, client-customized dictionaries)
    • SAE reconciliation
  • Computer System Validations
    • Auditing/compliance/validation
    • Data warehousing
    • Document management
    • Quality Assurance
    • Regulatory affairs
    • SOP’s
    • Technical writing
    • Training
    • Documentum