Investigator's Initiated Study
Clinical research investigators play a crucial role in the development of new medical treatments and devices. To support their work, various services are available. Here are some common offerings:
Regulatory Support
Protocol development: Assistance in drafting and refining study protocols that adhere to regulatory guidelines.
Regulatory submission: Guidance on preparing and submitting regulatory applications to relevant authorities.
Regulatory compliance: Ensuring adherence to Good Clinical Practice (GCP) standards and other regulatory requirements.
Site Management
Site selection: Identifying suitable research sites based on criteria such as geographical location, patient population, and investigator expertise.
Site initiation: Assisting in the activation and startup of research sites.
Site monitoring: Conducting regular monitoring visits to ensure compliance with the protocol and GCP.
Site closure: Overseeing the closure and archiving of research sites.
Data Management
Data collection: Providing tools and systems for efficient data collection.
Data entry: Ensuring accurate and timely data entry into electronic data capture (EDC) systems.
Data cleaning: Identifying and correcting data errors or inconsistencies.
Data analysis: Assisting with data analysis and interpretation.
Biostatistics
Statistical planning: Designing appropriate statistical analyses for the study.
Sample size calculations: Determining the optimal number of participants required for the study.
Data analysis: Conducting statistical analyses and interpreting the results.
Medical Writing
Protocol writing: Drafting and revising study protocols.
Report writing: Preparing clinical study reports and other regulatory documents.
Manuscript preparation: Assisting in the preparation of manuscripts for publication.
Quality Assurance
Quality control: Implementing quality control measures to ensure data accuracy and integrity.
Auditing: Conducting audits to assess compliance with regulatory requirements and GCP standards.
Training and Education
Investigator training: Providing training on GCP, study protocols, and other relevant topics.
Site staff training: Offering training to site staff on study procedures and data collection.