Whether your study aims at collecting safety and performance data, you need to support the clinical evaluation for CE marking or would like to pursue post market surveillance activities, the flexibility of 2Conduct´s module packages offers tailor made solutions for your specific needs.

Clinical trial services comprise the following modules:

  • Advice on study design
  • Preparation of all the documentation you will require for your study including:
    Investigator´s brochure
    Clinical investigation plan (protocol)
    Patient informed consent documents
    Case report forms, design and printing or electronic CRF respectively
    Investigator and institution agreements/contracts incl. financial arrangements
    Trial master file
    Investigator site files
  • Translation of study documents
  • Statistics, sample size calculations
  • Data management
  • Research Ethics Committee (EC)/Institutional Review Board (IRB) submissions
  • Submissions to Competent Authorities
  • Taking out study insurance policies
  • Selecting appropriate study sites
  • Organisation and conduct of investigator meetings
  • Performance of study initiation visits
  • Performance of study monitoring visits
  • Performance of study close down visits
  • Report writing (final report, publications, presentations)
  • Archiving of documentation