Your trial design and the way how you want to conduct trials determine the configuration of MARVIN – not the other way round!

Even if you are planning to do full technology transfer with us, it is unlikely that you will want to go through that process before having “tested” MARVIN. So we assume your first EDC trial with MARVIN is going to be hosted on XClinical servers.

A number of our sponsors have chosen to receive Data Manager Training during the first project. This enables them to set-up the e-CRFs, online reports, user roles, randomization, etc. themselves. But often, the very first trial is set-up with the help of the XClinical professional service team, which we will assume here.

The steps below can be performed partially in parallel to save time, which is why we do not number them.

• Study set-up
• Quality Management
  In general, but especially for regulatory relevant trials, the sponsor needs
  1. a set of SOPs according to which the trial (whether it is an EDC trial or not) will be performed. Sometimes, the sponsor requests that the trial is performed according to SOPs of a CRO. Sometimes, EDC specifics are not yet described in the SOPs. A quick and correct solution may then be to set-up a small set of study-specific SOPs that will at first only apply for one trial. The XClinical QA department can provide support to the sponsor in setting up the relevant SOPs.
  2. to perform a vendor audit at XClinical. The XClinical QA department has broad experience with such audits and welcomes your auditors at any time.
  3. to perform study-specific validation (which is a lot less effort than the system validation that is done under the responsibility of the vendor!)
• Site selection and qualification
• User and Investigator Training
• Study start
  How to provide passwords to investigators etc., site initiation, etc.

© XClinical GmbH, 2008