Project Management Services

The Strategic Project Management Solutions offer effective management of a clinical trial from the initiation phase to the closeout phase guided by well-defined standard operating procedures that comply with all applicable industry regulations and guidelines. A well-trained Project Team with expertise in a wide spectrum of therapeutic indications ensures to define the clear objectives for a trial, reduce roadblocks and work towards effective conduct of a trial for better study outcomes.

Project Management Plan (PMP)

Devise structured project plan for decisive communication and project governance, risk assessments and risk treatment plan to mitigate the risks of project failures, detailed work breakdown structure to overcome project setbacks, and to ensure deliverables are met within the defined timeframe and budget with the help of a highly available team of project experts.

Study Database Setup and Configuration

Professional Database designers develop and configure the study database after thorough protocol interpretation and constructively organizing the database specifications through an elaborate project requirement gathering process. The Clinical Database is set up in a highly configurable and flexible manner to incorporate mid-study changes without disrupting the trial in progress.

Setup Validation

The Study Database is validated through precise qualification procedures, exhaustive and comprehensive testing of the database is carried out internally to verify the study setup and configuration before releasing the database to UAT. Stringent Quality Control practices are followed to maintain validation checklists and document approvals to ensure compliance with regulatory standards.

Study Specific Training

Learn to easily and successfully manage your studies by deepening your knowledge on the use of the extensive product for general transactions or transactions specific to a study with the help of the Interactive Instructor-led Training held virtually through business communication platforms or on-premise training and self-learning videos accompanied by course exercises readily available in the tool.

User Acceptance Testing

A detailed test validation plan is devised and test scripts are developed as part of the validation procedures for study database testing to ensure the database is configured as per the project requirements. Standard documentation for UAT validation sign-off, traceability matrix is maintained for all testing.

Project Support

Consistent reviews together with the advanced discrepancy manager module helps to identify data issues and ensures a clean and complete database for the final analysis with data exports in .csv and .xls formats after database lock.

Online Training

A dedicated and highly accessible Support Team is assigned to each project to guide, support, and empower the customer team through intuitive high-level project planning to streamline the study activities, identify performance metrics and effectively monitor the project and status reporting to deliver stronger study outcomes on-budget and on-time.

Project Closure

Best practices are followed based on well-defined and documented procedures for study documentation maintenance and archival and to verify all study processes are complete as planned, sites closed out and system decommissioning. Study Reports are generated and analyzed to provide the sites with insights into the success of a study and anticipate necessary improvements if any for the next study.