Project Management
IDDCR project managers are intensely customer-focused and adept at building the optimal team for each trial – and at moving from concept to conclusive results while working in the most challenging indications like rare disease, oncology, and neuroscience. And while they’re devoted to delivering trial success to sponsors, they have an equally firm commitment to patients, physicians, and regulators.
Planning and Initiation
Study Design: Developing comprehensive study designs that align with regulatory requirements and scientific objectives.
Protocol Development: Creating detailed protocols that outline the study's methodology, procedures, and endpoints.
Feasibility Assessments: Evaluating the practicality and feasibility of conducting the study in specific regions or countries.
Site Selection: Identifying and selecting suitable clinical trial sites based on various criteria, such as investigator experience, patient population, and infrastructure.
Execution and Monitoring
Investigator Training: Providing training to investigators and their staff on study procedures, data collection, and regulatory compliance.
Patient Recruitment: Implementing effective recruitment strategies to enroll the required number of patients within the specified timeframe.
Data Management: Developing and implementing data management plans, including data collection, cleaning, and analysis.
Monitoring: Conducting regular site visits to ensure adherence to the protocol, data quality, and regulatory compliance.
Safety Monitoring: Tracking adverse events and ensuring patient safety throughout the study.
Reporting and Closure
Interim and Final Reports: Preparing comprehensive reports summarizing study findings, safety data, and regulatory compliance.
Regulatory Submissions: Assisting with the preparation and submission of regulatory documents to health authorities.
Study Closure: Overseeing the closure of the study, including final data analysis, archiving, and regulatory compliance activities.