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What is PharmaENGINE™?

When a patient participates in a clinical trial for an experimental treatment, they are giving much of their time and effort to ensure no one hears; “You have ALS” again. PharmaENGINE™ provides a secure, robust electronic data capture system for clinicians to record data collected during research visits to ensure the patient’s data receives the same care the patient receives in clinic. PharmaENGINE™ is our principal software used to manage clinical trials. PharmaENGINE™ was designed with data safety and security in mind.  It is a CFR 21 Part 11 compliant Electronic Data Capture (EDC) system and has been used to manage over 20 clinical trials in ALS and other Neurological diseases. Some of the key features of PharmaENGINE™ include:

  • Regulatory documentation tracking and reporting system

  • Patient prescreening, screening and screen failure tracking

  • Enrollment reporting

  • Visit tracking and scheduling of patient visits

  • Patient discontinuation/withdrawal tracking

  • Serious Adverse Events reporting and management

  • Protocol Deviation reporting and management

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