Profil offers high quality Data Management at competitive timelines. We always have an ear on new developments and we are ready to tailor our Data Management services to the needs of our customers.

• Team of six full time data managers, all with at least a Masters Degree
• Timeframe for a medium size study:
  three weeks from “Last Patient Last Visit” to database lock
  three weeks from database lock to key results
• Full data management completed for > 30 trials, in addition data management for a large multicentre trial (3,500 patients, > 10 million data points) performed
• Electronic lab data delivery (safety, PK/PD, tracer) for > 60 trials in various formats including OC, SAS, CSV, CDISC LAB
• Automated hourly lab data transfer from the local partner lab into Profil's database
• Flexible data export – almost any data format including CDISC SDTM and Oracle Clinical can be delivered
• SQL database for all data management activities (full 21 CFR part 11 compliance)
• MedDRA and WHO Drug Dictionary Enhanced licensed
• Electronic data capturing from heterogeneous sources (e.g. indirect calorimetry, ECG, lung function tests)
• Consulting about the most appropriate data capturing strategy (double data entry, electronic CRF, “Teleform” – our preferred, hybrid data capturing system)
• Experienced handling of Biostator^®-generated glucose clamp data
• Excellent data quality: <0.05% deviation between source and electronic data

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