Challenges in handling the investigator submissions and review process for the Pharma organizations
In the pharma organization, conducting the clinical trial is one of the most complex processes to conduct and execute which needs to be done with strict adherence to regulatory requirements, comprehensive documentation and discreet transparency. Among the complex process, reviewing the application submitted by investigators stands out as challenging. Documentation like Protocol Programs, progress reports and safety data are involved and managing the documentation ensuring compliance in handling large volumes of data effectively is tedious administrative work.
1.Managing Large Volumes of Submissions
Pharma companies often receive many IST/IIT requests simultaneously, each submission requiring going through trial lifecycle. Managing the heavy volumes of requests and large documentation from each request ranging from clinical trial protocols to Adverse events reports poses a tedious managing burden. If the administration process is not handled in the right manner, it can cause delays in reviews, results and errors and difficulties.
Solution:
Software products can provide a centralized document management system which can help pharma organizations to track and organize submissions more effectively. Advanced Workflows can help the organization users to route documents and applications for review, approval and further action without any user help making it more efficient.
2. Ensuring Compliance with Regulatory Requirements
The pharmaceutical industry is heavily regulated, which includes good clinical practice (GCP) guidelines, FDA requirements and international regulatory guidelines. To ensure each investigator complies with all the applicable guidelines for submission needs to be monitored and can be challenging. Additionally, there are frequent updates to the regulations across different regulatory bodies. The non- compliance can lead to delays, legal problems and termination of trails submissions.
Solution:
Software products can provide organizations with updated regulations in the product so that pharma organizations are updated on regulatory changes and there are multiple features to enable both the internal and external user to learn and apply the latest regulatory changes. In this manner both organization users and the investigator know about the regulatory changes, and it would be helpful to review the application without the fear of trail rejections.
3. Ensuring Data Integrity and Accuracy
The primary challenges in handling investigator submissions are tracking and organizing the accuracy of the data. Investigators’ submission is often critical clinical data including study protocol, study design, including patient demographics, medical history and adverse events. If the data is maintained inappropriately the credibility of the study becomes questionable. It would lead to invalid results and patient safety becomes at risk.
Solution:
Software products provide data validation provisions and automated data checks which help reduce the risk of errors.
4. Coordinating with Multiple Stakeholders
The investigator submission and review process include co-ordination between various team stakeholders, including clinical team, research team, patent team, regulatory bodies and various other departments like legal and operations. Managing this collaboration and conducting the review process is a key challenge as each team member group may have different requirements and priorities.
Solution:
Software products provide email correspondence to communicate efficiently within internal and external users; this can be used for passing information or collecting relevant information to conduct the review process more effectively.
5. Ensuring Timeliness in the Review Process
The review process of the application submitted by investigators needs to be done in a timely manner as it is crucial in avoiding delays in the trial’s progress. The review process can be lengths, as it includes multiple rounds of reviews. There could be sub-sequential effect on the trial timeline, leading to increased cost or missed opportunities if the review process is not done in a timely manner.
Solution:
To conduct a comprehensive review process, software products can provide integration with Microsoft 365 and Google Docs to provide an efficient online collaboration review cross checking by multiple stakeholders. This feature ensures the submitted applications are accurate before they are moved on to approval stage.
Conclusion
The investigator submission and review process are primary activities that are involved in successful IST submission. However, managing various other challenges like communications and coordination for organizations is tedious. By leveraging SCIMAX IST, the entire workflow can be streamlined, ensuring compliance and focusing on data integrity and security. SCIMAX IST provides solutions to problems like communication and coordination and improve efficiency. As a cloud-based platform it can facilitate secured data sharing and collaboration across different teams. SCIMAX IST provides features like submission tracking, integrated review platform to enhance productivity.
Author
Sharath Anil
Associate Director – Product Management
