Clinical Trial Operations

Data Management of more than 100 clinical trials (Phase I-IV), post-marketing studies and other empirical surveillances. The clinical trials spread therapeutic areas like gastroenterology, cardiovascular diseases, women's health are, oncology, dermatology, metabolic diseases, CNS, intensive care, pulmonology, pain, infectious diseases and urology.

The operations included more than 45.000 subjects processing over 600.000 CRF pages (with approximately 50 pages/subject). The trials were conducted in about 20 countries worldwide, including Germany, France, Spain, Brazil, Lithuania, Hungary, Romania, Ukraine, Russia and others.

Consultancy

Trans-Net has been involved in the implementation and customization of the Oracle Life Science Data Hub (LSH) solution in the industry. We have successfully migrated several pharmacovigilance systems (Clintrace, Argus Safety, ARISg and Oracle AERS) and clinical data management systems (Clintrial, PhOSCo, etc.). We have supported the validation of several Clintrial installations in an enterprise scenario.

We have customized CDMS for enhanced query management and integration into the software environment of several companies. Trans-Net has developed software for reconciliation of SAE reports between Clintrial and Clintrace. For Pharmacovigilance Units we have programmed Periodic Safety Update Reports (PSURs) and interfaces for E2B reporting. We were involved in the MedDRA deployment for clinical systems.

We helped in selection process for new CDMS, including conduction of user requirements, implementation and resource planning for global playing companies.

Pharmacovigilance

About 4000 adverse drug reaction reports were processed by Trans-Net in the last year (2007). Depending on the requirements of the customers, processing of the cases included data entry, coding, quality review, medical review, causality assessment and labeling. According to the needs of the companies the data entry of more than 3000 cases was processed in a 24 hour timeframe, no matter whether initial-, follow-up-, spontaneous-, study-, or literature cases.