Data Management (Statistics and Medical Writing)

Profil has delivered high-quality data management in more than 60 trials with competitive timelines (on average 3 weeks from LPLV to database lock). Final databases can be delivered in all currently used formats, including OC and CDISC SDTM.

We enable sponsors to have secure, real-time access to lab data plots and stand ready to tailor our data management services to your needs.

The newest addition to our portfolio of tools that enable quicker insight into ongoing trials is edy, an in-house developed EDC-solution. edy is specially designed for phase I trials with short setup and changing timelines in mind (e.g., due to amendments). edy is of course fully validated, 21 CFR part 11 compliant, and offers everything a modern EDC-solution should have.

• Twenty data managers: recruitment and retention of high caliber, experienced staff
• Average timelines: three weeks (15 working days) from LPLV to final database lock
• Flexible data export in any data format, including CDISC SDTM and Oracle Clinical
• Electronic lab data delivery (safety, PK/PD, tracer) for > 100 trials in various formats including OC, SAS, CSV and CDISC LAB
• Automated quarter-hourly lab data transfer from the local partner clinical lab into Profil’s database
• Live view for sponsors into lab data and plots through a secure web interface
• Full 21 CFR part 11 compliance

Our four statisticians collaborate closely with the data management team and can directly access the SQL database that is the backbone for all data storage from SAS. The team has been responsible for SAP creation, statistical analyses and TLF output in over 40 trials. The TLFs can be generated according to our standard format, CDISC ADaM, or adapted to any sponsor request. The usual timeframe is to deliver key results two weeks after database lock and TLFs one week later. In addition to SAS, WinNonLin is available for pharmacokinetic and pharmacodynamic modeling.

Our medical writers have extensive experience in creating clinical study reports. The standard timeframe for the first draft of the CSR is three weeks after the statistical results are available.