Philosophy
ProcClinSafe® software will be a welcome component of any Pharmaceutical, Biotech or Device organization as they go through the four phases of development in their clinical trials. Specifically, ProcClinSafe® targets the Safety component of Clinical trials from the onset of a trial till the end. ProcClinSafe®, as the name suggests, is a compilation of procedures or programs that are based on the industry standard software SAS®. ProcClinSafe® automatically generates a plethora of Safety reports (Tables, Figures, and Listings) to assess clinical Safety signals during a trial. This adds significant value to functions of the Clinical, Medical, Safety and Pharmacovigilance teams as they can obtain fast, accurate and in-depth reports on the Safety of the clinical program. With ProcClinSafe® one is only limited to how fast data can be retrieved. Rather than waiting for several hours or days, these internal and external customers can now get results in literally minutes if not seconds.
Scope
ProcClinSafe® software produces almost five hundred reports spread across nine Report templates. These reports include but are not limited to typical reports seen in Clinical Study Reports (CSRs) , Data Monitoring Committee (DMC) and Development Safety Update Reports that aid in identifying Safety signals. The source data includes Demography, Adverse Events, Clinical labs, ECGs, Vital Signs, Exposure, Concomitant Medications and Medical History. The software accepts integrated datasets so generating Integrated Safety reports is a breeze.
Ease of use
ProcClinSafe® is a User-Friendly, Point-and-Click Interface for rapid, comprehensive Safety Surveillance reports. There is absolutely no programming involved or even the need to set up a directory infrastructure by the user; it does it all for you! Some reports take as much as half a second to generate although the average standard report takes just over a second to generate (results may vary depending on the speed of your computer). The software has many customizations on the cosmetic and output aspects as well as on the report specification aspect and will even assist on the metadata specification.