Clinical Adjudication Services
A successful journey begins with a successful plan. That’s why, instead of treating clinical adjudication as an afterthought only brought up once a patient event has occurred or an endpoint is reached, PAREXEL® includes potential need for an adjudication in clinical trials planning, including the specific data to be collected.
Clinical adjudication has proven to be highly effective at pinpointing and helping identify and address potential issues with new therapies and making “go/no go” decisions early, saving critical time and funding.
PAREXEL’s Clinical Adjudication Services are fully integrated into our clinical trial services infrastructure and offer a holistic, global, technologically advanced, and therapeutically flexible adjudication program.
Our capabilities include:
- Identification of chair and members for adjudication committee
- Contract with and management of members
- Preparation of the Charter of Operations document
- Events to be adjudicated/identification/alert
- Source documents to support event
- Review process
- Adjudication questions
- Preparing Operational Procedures and Data Entry Guidelines
- Preparing and distributing event dossiers/profiles via VCAS
- Translation, review for subject de-identification
- Manage review rounds, final results
- Project management / report events status
- Meeting management: Orientation and Consensus
- Build/Configure the Virtual Clinical Adjudication System
- Data transfer and end-of-study file transfer