store clinical data - private And gcp compliant
share with selected partners - easy and safe
BE GCP compliant and avoid:
unsafe public cloud tools
unsafe emails with zip-files
If you need to exchange and store clinical data and documents, we can offer you our validated file sharing product: CLIN-LINK - an easy and safe solution.
CLIN-LINK is developed and maintained by Signifikans, a full data services company within pharma, medico and biotech.
We have identified, during our many client relations, a strong need for sharing and storing all sorts of clinical data and documents in an easy, safe and GCP and GDPR compliant manner. Sharing might be receiving data from a central laboratory in Finland or collecting scans from participants in clinical trials conducted on sites around the world. For data monitoring committee (DMCs), it might be distributing data packages to unblinded DMC members using an easy and safe tool. Also, during and after clinical trials, a tool is needed for storing documents (e.g. Trial Master File) and clinical data for later submissions.
Traditionally, the sharing of clincial data has been performed via email using password-protested zip files (not safe or easy to use), over public cloud solutions like SharePoint or Dropbox (unknown data flow and impossible to determine where the data is stored or who has access), or by using s-FTP solutions (safe yes, but not user-friendly). All of these traditional solutions are either unsafe, hard to use, or non-compliant with authority requirements (GCP and GDPR).
What we can offer is CLIN-LINK: The easiest to use software in file handling on the market (Nextcloud), configured with state of the art security and installed on your own PRIVAT cloud server - unique for each individual client. CLIN-LINK is validated, for each client, to prove compliant with GCP and GDPR. The compliance report can be used for audit.
We have already many years experience with CLIN-LINK and a strong cloud team - we can't wait to serve you as a client.
Andreas Habicht, CEO at Signifikans