- Expertise in IIT Management: Thanks to the experience of working with investigatorinitiated studies. Protheragen understands the characteristics and challenges associated with IITs.
- Comprehensive Solutions: For the achievement of the goal set forth by investigators, we provide a one-stop solution as regards trial management.
- Regulatory Excellence: Protheragen complies with the appropriate requirements and develops policies and procedures designed to maintain the integrity, quality, and compliance of your trial.
- Collaborative Approach: We meet with our researchers to understand their vision and give tailored assistance throughout the entire process.
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Investigator-Initiated Trials (IIT) Services
Protheragen plays a pivotal role in supporting investigator-initiated trials (IITs) by offering expert assistance throughout the entire process. We provide guidance on preclinical research, help refine translational research ideas focused on MyD88 target-related therapies, and ensure efficient progression to clinical stages. Our services help accelerate the development of novel MyD88 target-related treatments and facilitate the exploration of new therapeutic approaches for MyD88-related diseases.
Introduction to Investigator-Initiated Trials
Investigator-initiated trials (IITs) are clinical studies led by individual investigators or research institutions, rather than pharmaceutical companies or sponsors. These trials focus on exploring new therapies targeting MyD88-related diseases, testing novel approaches, or gaining deeper insights into the role of MyD88 in various pathologies.
IITs play a vital role in advancing medical knowledge, offering researchers the opportunity to address existing challenges related to MyD88 and discover new therapeutic strategies for MyD88-associated conditions.
Fig.1 The Pharma Drug Development Cycle. (Harrer, S., et al., 2019)Advantages of Investigator-Initiated Trials
In comparison to other trial types, the investigator-initiated trials have some notable advantages and due to these advantages, the IITs constitute one of the cornerstones of clinical investigation.
Filling In Clinical Needs
Commercialization has a tendency to eclipse research in that it is so difficult to fill in clinical needs especially for rare diseases and to bring new mechanisms into practice. Still, pharmaceutical companies can make use of IIT to study therapies and indications that are not main targets.
Adaptability and Creativity
IIT's make it possible for investigators to pursue new hypotheses, combination therapies, drug repurposing, or other types of targeted populations. Because of their nature which is unrestrictive, creativity and innovation are encouraged especially in the design and conduct of the trials.
Prompt and Less Expensive
Due to absence of market constraints, IITs can be set and run much faster than commercially driven trials. In addition, grant funded IITs that are from a university, government or nonprofit organization provide a cost-effective means to resolve important clinical needs.
Our Services
Protheragen provides a comprehensive suite of investigator-initiated trial (IIT) services, specifically focused on MyD88-targeted therapies. These services are designed to support investigators throughout all phases of clinical studies, from preclinical research to clinical trials.
Protheragen's IIT Services
- Document Preparation and Submission Support
The support that is offered aims at preparing and filing documents as well as filing papers for preliminary trials to streamline obtaining documents from the concerned parties.
- Study Protocol Assessment
Local project investigators can be assisted to contact regulatory and local medical authorities for the effective implementation of the project.
- Liaison with Authorities and Medical Institutions
Assistance is rendered at a basic level on the reviewing and amending of study protocols so that a greater degree of compliance and feasibility with the protocol is obtained.
- Approval Document Preparation
It is possible to prepare other documents in collaboration to assist in obtaining the approval of the project and in other areas where this is necessary.
- Regulatory Compliance Guidance
Ensuring that the study meets all relevant local, national, and international regulatory standards throughout the trial process.
- Patient Recruitment and Retention
Strategies and support for recruiting and retaining patients in the clinical trial, ensuring sufficient participation and valid data throughout the study.
Why Choose Protheragen?
Involving Protheragen in the execution of investigator-initiated trials (IITs) significantly reduces the workload of your research and enhances the quality of your clinical trials. Additionally, we offers upstream services, including therapeutic discovery services, disease model development, pharmacokinetics and drug safety evaluation. These services streamline the process from early-stage discovery through to clinical trials, providing a comprehensive solution for MyD88-targeted therapies.
If you are interested in our services, please don't hesitate to contact us.
References
- Bai, H., and S. Zhang. "Challenges of Investigator-Initiated Clinical Trials to Support the New Drug Development." Zhongguo Fei Ai Za Zhi 25.7 (2022): 511-16.
- Herfarth, H. H., et al. "Investigator-Initiated Ibd Trials in the United States: Facts, Obstacles, and Answers." Inflamm Bowel Dis 23.1 (2017): 14-22.
- Harrer, S., et al. "Artificial Intelligence for Clinical Trial Design." Trends Pharmacol Sci 40.8 (2019): 577-91.
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.