Clinical Trials
Currently, there are clinical programs involving thousands of patients underway at Cephalon. These programs measure the value of Cephalon scientific innovation in distinct therapeutic areas where we have the most knowledge and expertise.
Effectively managing the clinical process requires bringing together a range of supporting professional disciplines, all united to help patients, physicians and regulatory agencies make informed decisions about our products and their impact on human health.
Patient safety
Our approach to risk minimization is proactive, applying advanced technologies for signal detection to pinpoint safety risks early on in drug development. These technologies, such as mining of databases to uncover patterns that indicate potential safety issues, help Cephalon predict risks and focus pharmacovigilance efforts where the need for attention is greatest.
Quality control and assurance
Following procedures defined by regulatory agencies, Cephalon ensures that clinical research methods meet or exceed the procedures for approval. These standards ensure that data is generated, documented and reported in accordance with protocols and regulatory requirements.
Biometrics
Cephalon biostatisticians develop carefully-designed analysis plans to achieve accurate interpretations of data gathered in clinical trials. Data models constructed with this methodology enable Cephalon to characterize meaningful safety and effectiveness profiles on new drugs and new indications for existing compounds.
Regulatory affairs
Cephalon works closely with regulatory agencies to understand evolving regulatory requirements, and to provide access to clinical data needed for decision-making about our medications. We’re committed to continuous improvement in the clinical trials process and to helping regulatory agencies understand what kinds of trials are needed to meet patients’ needs.