Services

Clinical Data Managment

Brightech is recognized as an innovator shaped by our industry-leading approach, clinical data methodology and client-centric focus. Our integrated and comprehensive clinical data management approach results in a high quality seamless end-to-end management of your clinical trial data. We develop a partnership with our clients that enables effective decision-making and cost efficiencies.

Brightech’s Data Management Team will work hands-on with your team to design a nimble and scalable solution based on your specifications and needs. This process is optimized to ensure that we effectively and efficiently capture, maintain, clean and deliver data for your project regardless of study phase, therapeutic indication, or method of data capture.

Brightech’s highly experienced team of data managers, database developers, technical support personnel, and SAS programmers manage these processes utilizing a platform agnostic approach or by leveraging our integrated Clinical Information Management Suite (CIMS) to support your study requirements.

Solutions

Comprehensive Support

• Case Report Form (CRF)/eCRF and Database Design

• Data validation, review and cleaning

• End-to-end support for diverse streams of third-party data

• Independent database audits and Quality Control assessments

• Medical Coding

• Reconciliation of safety data

• Data Monitoring Committee (DMC) support

• Strategic partnerships

• Flexible and scalable working model

Proven Approach

• Early proactive planning, development and training

• Risk management and contingency planning

• Close and regular communication with client

• Ongoing oversight and communication with vendors and project team

• Development and maintenance of project specific documentation

• Resource and budget management

• Perform ongoing quality checks for all processes

• Routine metric reporting

• Proactive identification and resolution to questions

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