Bringing pharmaceutical and biotechnological therapeutics or medical devices to market is an endeavor that can typically span over a decade and cost manufacturers amounts in excess of a billion (US) dollars. Under these conditions, improvements in efficiency and agility that result in shortening these products’ time-to-market have impacts measured in multi-million dollars. Information Technology (IT) solutions allow therapeutics and device manufacturers to better integrate all those internal and external organizations involved during their pre-clinical and clinical development activities.
USDM has accrued extensive experience in validating a multitude of core applications that support pre-clinical as well as clinical development activities. We have validated, qualified, managed deployments and provided QA review support activities for IT solutions utilized during pre-clinical and clinical development activities. Our approach is to leverage our extensive experience with industry-wide utilized applications to proactively contribute to reducing deployment times of cGxP-governed IT solutions. Our experience with validating 400+ cGxP-governed IT solutions allow us to be agile and precise while bringing validation projects to completion.
Some of the IT solutions we have experience in include:
- Laboratory Information Systems (LIMS)
- Pharmacokinetic/Pharmacodynamics (PK/PD)
- Clinical Trials Management Systems (CTMS)
- Electronic Data Capture (EDC)
- Interactive Voice Response Systems (IVRS)
- Electronic Common Technical Document (eCTD)
- Drug Safety Systems
- Bio-Statistical Data Analysis Systems
- Corrective Action/Preventive Action (CAPA)
- Enterprise Resource Planning (ERP)
- Learning Management Systems (LMS)
- Electronic Document Management Systems
- Change Control Systems
- Labeling/Packaging Systems
- Calibration Systems
