Regulatory Close Out
IRB submission, adverse event reporting, TMF completion.
Site Close Out Visits
Completion of all site documents, IP return, accountability, and destruction.
Archiving of all trial-related materials including raw data, CRFs, source, regulatory files, and biological samples.
Data Lock and Analysis
Quality assurance and audits, query resolution, final study report preparation.
Reporting and Publication Support
CSR development, publication drafting, public disclosure and notification of trial completion.
Our Featured Services
We can provide full-service clinical trial close out support, or individual services to meet your needs. We support you in ensuring all aspects of your trial have been completed in accordance with regulatory requirements, the study protocol, and all ethical standards.
Streamline your trial management with our TMF completion service. We guide regulatory compliance, organization, and completeness of your Trial Master File, reducing administrative burdens.
Data and Sample Archiving
Secure your data and samples for as long as required. We provide a reliable, organized, and compliant solution for long-term storage and retrieval of both digital data and physical samples.
EDC Lock and Data Export
When using our custom-built EDC, data query resolution and data lock are simple and efficient. We secure your data, ensuring compliance and seamless export for analysis and reporting.
CSR and CER Development
Our team of expert medical writers craft comprehensive, compliant, and compelling clinical study reports and clinical evaluation reports to support your regulatory submissions.
Close Out Payment Reconciliation
Streamline trial closeout with payment reconciliation. Ensure accuracy and compliance in financial transactions, saving time and resources.
Don’t Make These Mistakes at the End of Your Trial
The following mistakes are commonly seen during clinical trial close out, leading to inefficient project management and delays in regulatory submissions:
- Inadequate Documentation: Failing to maintain comprehensive records and documents, which can lead to regulatory issues and data gaps.
- Incomplete Data Analysis: Neglecting thorough data analysis, potentially missing crucial insights.
- Inaccurate Reporting: Errors or omissions in final reports can compromise the validity of study outcomes.
- Regulatory Non-Compliance: Overlooking regulatory requirements during closeout, leading to regulatory scrutiny or delays.
- Budgetary Oversights: Underestimating the costs associated with closeout activities.
- Timeliness: Not adhering to planned timelines, causing unnecessary delays.
- Ineffective Communication: Poor communication with trial sites and investigators can hinder the closeout process.
- Data Security: Failing to adequately protect and archive sensitive trial data.
- Insufficient Training: Inadequately trained staff involved in closeout tasks can lead to errors.
- Lack of Contingency Planning: Not preparing for unexpected issues that may arise during closeout.
Avoiding these mistakes requires careful planning, attention to detail, adherence to regulatory guidelines, and effective communication among all stakeholders involved in the clinical trial closeout process.
Need to Store Liver Biopsy Specimens at the End of a NASH Trial?
Specialized freezers and cryopreservation techniques allow samples to be preserved at very low temperatures, ensuring long term stability. Stringent security and tracking systems maintain the integrity of stored samples long after clinical trial close out.
Formalin-Fixed Paraffin-Embedded (FFPE) Blocks
FFPE allows for long term storage of tissue samples at room temperature. This method is perfect if you are planning for future histopathological examinations, immunohistochemistry, or molecular studies.
Frequently Asked Questions
Now that you’ve completed your trial, a trusted expert can help you complete the process. Here are answers to some common questions about essential clinical trial close out activities.
To end a clinical trial, the sponsor or principal investigator follows predefined protocols: data analysis, regulatory reporting, closeout site activities, and final documentation for regulatory submission.
The sponsor is primarily responsible for orchestrating the clinical trial close out activities and regulatory compliance. Working with a strong CRO can provide guidance to help ensure the sponsor meets all requirements.
A clinical trial can be terminated prematurely due to various factors, such as safety concerns, lack of efficacy, protocol violations, or sponsor decisions.
After a clinical trial is completed, data analysis, regulatory reporting, and closeout activities occur. Successful trials may proceed to regulatory submission and, if approved, market launch.