YES TO
GCP and GDPR compliance clinical file storage
(Very) easy sharing of clinical files and documents with external partners
PRIVAT cloud - top security
NO MORE
Attaching of clinical files and documents in emails
Unsafe public cloud tools for clinical files
Data leak, not even meta data
Our clients use CLIN-LINK for:
- Collection, storage and sharing of clinical data files (data, videos, documents)
- Electronic trial master file (eTMF) maintenance and QC, using DIA reference model
- Collection and storage of laboratory results
- QA administration (SOP, vendor, audit documentation, GxP systems plans)
- Distribution of data packages to DSMB members (OPEN and CLOSED access areas)
- Distribution of large files with sensitive information to site for study initiation
Much more...
“CLIN-LINK really saved the project. It was of great comfort to know, that latest versions of all files were on CLIN-LINK, and not locally on project members PC.”
“Please use me as reference - we use CLIN-LINK a lot and find it very easy and useful.”
“CLIN-LINK is just what we need. We have become really happy to use the CLIN-LINK feature to share large documents that are difficult to send on email.”
“We are happy for CLIN-LINK and use it a lot.”
“Please use me as reference.”
If you need to store clinical files GCP compliant and share with external partners safe and easy, we can offer you one integrated and validated file sharing system: 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 storing and sharing all sorts of clinical files and sensitive documents in an easy, safe and GCP and GDPR compliant manner. Sharing might be sending a link with study initiation material to site, 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.
Best regards,
Andreas Habicht, CEO at Signifikans
The product
Learn more about CLIN-LINK features and functionality (learn more)
Validation
Validation process based on GAMP 5 and GCP (R2) (learn more)
Security first
Clinical data demands high security by default (learn more)
Compliance
Full compliance with GCP and GDPR (learn more)
Client cases
View cases from our clients (learn more)
How to start
Try CLIN-LINK (Learn more)
