Clinical Trial Readiness: Five Key Steps to Ensure Success
Advancing a product or service into clinical trials is a major milestone that requires meticulous preparation. Even minor errors at any stage of the trial can lead to costly delays. Beyond study design, clinical site selection, and investigator selection, numerous details must be addressed.
Through CRO Consulting’s extensive experience in clinical trial management and operations, we have identified five key elements that Sponsors must consider before initiating a clinical trial. Close collaboration between the clinical operations, R&D, and manufacturing teams is essential to ensure resources are properly scheduled. Below is a checklist that applies to in-vitro diagnostic products but can be adapted for medical devices and pharmaceutical products.
1. Investigational Product and Comparator Tests: Assays
Conduct limit-of-detection testing on at least two lots and review results with the R&D team to ensure they meet minimum requirements before shipping to clinical sites.
Perform specimen transport and storage stability studies to confirm acceptability.
Confirm that comparator tests are available and in inventory to supply to clinical sites.
2. Investigator Training
Ensure all team members involved in the trial, including staff at all levels, receive proper training.
Maintain thorough training documentation to demonstrate compliance with study and regulatory guidelines.
3. Data Management and Quality Assurance
Verify the data collection platform is prepared to receive study data.
Ensure all data is collected and stored in compliance with study protocols.
Implement quality control measures to maintain data integrity.
4. Contracts and Document Approvals
Execute and document contracts with all participating vendors before trial initiation.
Obtain Institutional Review Board (IRB) approval for all study documents, including forms, templates, and recruitment materials as needed.
Submit financial disclosure forms for all individuals with financial involvement in the trial.
5. Manufacturing and Product Supply
Ensure product validation lots are available with Investigational Use Only (IUO) status and released for use.
Confirm all products included in the trial are properly labeled per regulatory and study requirements.
Establish a steady supply of the product throughout the trial.
Verify that transportation, storage, and refrigeration (if applicable) meet all the documented requirements.
Thorough preparation for a clinical trial maximizes efficiency and minimizes potential setbacks. The National Institute for Health Clinical Trials Toolkit website has additional information on clinical trial preparation that may be useful for your study.
The team at CRO Consulting is well-equipped to guide you through the clinical trial process. Contact us today to learn how we can support your trial’s success!
