Clinical Services

  Plenum Scientific Research, provides efficient, cost effective Contract Research Organization (CRO) services to the global medical device/Health Care/ Pharmaceuticals  community. We work with the client to design or execute part or all of a clinical trial. Plenum Scientific Research approach allows the client to maintain control while realizing the benefits of outsourcing.

Plenum Scientific Research, the device choice CRO+, specializes in medical devices/ Health Care / Pharmaceuticals and biological products with willingness to work with you to achieve your goals within your cost and schedule constraints

Key Benefits

Experienced Staff: Our qualified professionals span all necessary areas of expertise and have completed scores of clinical trials successfully. In addition, our clinical consultants are supported by regulatory and compliance staff to provide the comprehensive results you need.

Tailored Trial Management: By partnering with you, we maximize your clinical resources and provide the expertise and flexibility you need within your budget. Plenum Scientific Research assigns an experienced professional to lead each clinical project. Therefore, efficient communications is accomplished by interfacing with a single Plenum Scientific Research representative.

Global clinical Resources: With our affiliates in India / Canada, Plenum Scientific Research can assist in expediting your International submission as well as supply you with clinical professionals knowledgeable in clinical trial management outside of the United States.

Clinical Research Support Areas

Trial Design/Strategy

  • Literature Searches and Bibliographies
  • Device IDE Protocol Preparation
  • Technical Papers and Abstracts
  • Pre-clinical Protocols
  • Statistical Plan

Data Management / Quality Assurance

  • Database Development
  • Biostatistics
  • Audit Preparation and Support - BIMO
  • Data Entry
  • Data Analysis

Trial Management

  • Clinical Management Plan
  • Trial Design
  • Physician and Study Center Recruitment
  • Compensation Agreements
  • Monitoring
  • Case Report Form Design
  • Investigator Agreements
  • Patient Recruitment

Reports/Submissions

  • Product Specific Strategies
  • IDE/PMA Annual Reports
  • Adverse Event Reporting
  • IRB Submissions
  • CE Mark Clinical Dossiers
  • Post Market Studies
  • Outcomes Studies

Plenum Scientific Research  is a coordinated team of experts who serve to bridge the gaps in clinical, regulatory and compliance for the global medical device / Health Care / Pharmaceuticals community.