We map your study data to CDISC SDTM
How our service works
Select the service you need and register
Confirm your email and phone number
Upload the required documents:
1. Zip file of data
2. Protocol
3. Blank crf
(4. Sponsor requirements)
Receive confirmation on successful uploads and a time table
Follow the progress on the webpage
Download draft versions of output
Report and resolve issues in the online issue-tracker
Receive zip file for download including the following documents:
1. SDTM datasets in SAS and XPT formats
2. Commented OpenCDISC report
3. Define.xml
4. SDTM Annotated CRF
5. List of open issues in the issue-tracker
You perform CRO oversight and review the three deliverables and upload comments using the online issue-tracker.
Download your Submission deliverables:
1. SDTM datasets in SAS and XPT format
2. SAS programs, exported with sponsor defined libname statements. (One program pr. domain)
3. Define.xml
4. SDTM Annotated CRF
5. Commented OpenCDISC report
The Service follows a simple 6 step process.
Some of our Product features.
All Clinical Data is encrypted in transit and at rest using Amazon Web Services. Servers are protected by Security Groups restricting both inbound and outbound traffic.
Follow the process on the webpage on the MyStudies Dashboard. Download draft output on-demand.
Recieve one independantly runnable program pr. SDTM Domain. Tell us about your environment and we will prepare sponsor libnames so that they will run directly in your environment.
All Uploads and downloads of Clinical data use an Encrypted https protocol. Data at rest are stored on Encrypted drives.
Report and resolve issues in the online issue-tracker while your output is being prepared.
Our environment adheres to GCP and 21 CRF part 11 principles. All validation documentation (VMP, VP, RS, FDS, VR) are available on demand
We use strong password rules and two-factor authentication. We therefore need you to confirm your email and phone when you register for an account.
Upload Sponsor specific requirements (e.g. SDTM Data Model, Code lists, Specific Test/Testcds, trial design requirements).
Receive submission ready deliverables (SDTM domains, define.xml, Annotated CRF and commented OpenCdisc report).
Compare our different packages to find out what package suits your needs.
Check our Frequently Asked Questions below to get your questions answered.
Yes, all Clincal data are uploaded using an Encrypted HTTPS protocol. Data at rest are stored on Encrypted drives. Clinical Data is keept on Servers protected by Security Groups restricting both inbound and outbound traffic.
Our enviroment adhere to GCP and 21 CRF part 11 principles. All validation documentation (VMP, VP, RS, FDS, VR) are available on demand. All our processes are described in Standard Operation Procedures.
Yes, We have strong password rules and require Two-Factor Authentication. Further more all traffic is done over an encrypted HTTPS protocol.
Yes, Send us your Sponsor specific SDTM model or Terminology and we will develop according to that (Premium and Bussiness packages only)
If you have any questions to the service then please get in touch.