After the successful completion of phases I to III, phase IV studies investigate an approved drug in the widespread treatment of patients. The particular benefit of the Phase IV studies is the comprehensive documentation of the tolerability of the medication with a higher number of cases subject to meticulous documentation of side effects and interactions with other medication. The incurring data volumes in phase IV studies are consequently large and require complex editing systems that facilitate intelligent error correction and error prevention.
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With our OPVERDI and PMSBOX software, we offer our clients’ customizable rapid data capture and data transmission for all project participants. Both documentation systems are accessible to authorized staff via the Internet. Thus, investigators and all project members involved can access all relevant data of the Phase IV studies anywhere at any time. The team at Dr. Oestreich + Partner is always available to all project staff to answer any questions or solve any problems which may arise without delay. The software can be flexibly adapted to the phase IV studies and also incorporates external data such as images from diagnostic procedures, laboratory results or ECGs. The documentation systems facilitate the electronic generation of all required documentation forms (eCRFs) in all languages for phase IV studies. At the same time, Dr. Oestreich + Partner offers a reliable compliance monitoring system for clinical research. Our team of experts from a wide range of medical fields provides competent advice on compliance with all regulatory requirements and good clinical practice (GCP).
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