Investigator Initiated Trial (IIT) Services
Investigator Initiated Trials (IITs) offer an opportunity for change and progress in the field of medicine, and thus form an integral part of the clinical research ecosystem. Protheragen offers full-service clinical trials from submission of documents and regulatory assistance to upgrading facilities and partnerships.
Investigator-Initiated Trials (IITs) are investigational studies which are not sponsored or initiated by any drug or device companies. Instead, they are conducted by the physicians themselves. These trials greatly aid in accumulation of new medical knowledge with improved patient care as they involve either additional off-label uses of an already approved product or the development of new label or tesing the existing products in the market which is not cost effective for the company to pursue.
Fig.1 Investigator initiated trial workflow within BISR. (Mudaranthakam D. P., et al., 2020)
IITs revolutionise how healthcare practitioners participate in research and enable them to answer questions important to everyday practice. This type of study generates clinical data about safety, efficacy, and the use of an intervention which helps inform medicine guidelines and clinical practice.
| Item | Challenges | Solutions |
|---|---|---|
| Financial and Resource Constraints | One of the primary challenges investigators face is having insufficient funds and resources to appropriately conduct an IIT. Most of the time, researchers are not adequately trained in biostatistics, data management and medical writing which are crucial in carrying out their studies. | One of the key facets that would be crucial in insurers to the researchers, is teamwork especially for the investigators to have experienced professionals in all their research work for every step of the research. Experts can assist investigators in developing rigorous study designs, obtaining the right funding, executing the study, and analyzing the data. |
| Regulatory and Ethical Complexities | Working through the regulatory framework and getting the required consent from institutional review boards (IRBs) or ethics committees is rather problematic, especially in the case of IITs which are likely to pose more than minimal risk. Also, taking into account local laws and regulations applicable to clinical research is very important. | It is important to have well trained regulatory affairs specialists who understand the nuances existing for different regions. They are able to assist investigators in preparation of all required documents, approvals, and compliance for the entire duration of the study. Understanding of the regulatory status can accelerate such processes and avoid complications. |
| Operational Challenges | Patient and data management, as well as study coordination and safety monitoring, are necessary components of an IIT. Unavailability of trained experts and proper infrastructure at clinical study sites is the main issue that would impede proper IIT conduction. | Operational support comes in handy too, after all. Furthermore, the successful conduction of IITs rely heavily on the establishment of well fitted clinical trial coordination centers and offices, thorough logistics and data management, as well as equipment and safety monitoring. All of these components work hand in hand with a wide network of clinical centers and hospitals for easier patient enrollment and study conduction. |
Protheragen embraces assisting in the conduct of investigator-initiated trials also referred to as IITs by offering support services that suitably resolve challenges encountered by the investigators. Our aim is to assist our clients in successful bringing up the desired therapies needed for various conditions within a short span.
Compliance Approval
Our initial phase services include obtaining regulatory approval to ensure that all research activities comply with ethical standards and legal requirements. This step is critical to safeguarding the rights and welfare of research participants.
The screening process was rigorous, and we focused on factors such as nationality, occupation, residence, and health status to ensure that the study population was representative and relevant to the study objectives.
Protheragen works alongside hospitals and medical centers in gathering clinical information for the study. This step is carried out in such a manner so that the data collected is of the highest quality and can withstand any scientific evaluation as all the protocols and latest tools are utilized.
Throughout the course of the trial, Protheragen performs a number of quality control checks. These include but are not restricted to regular audits, data checking, and mid-term analysis so that the study is always on course and fulfils the highest of scientific requirements.
Service Delivery
Last but not the least, Protheragen guarantees the timely provision of research outcomes by deploying methods for efficient and secure data transfer that protect the integrity and confidentiality of the research data.
By leveraging Protheragen's comprehensive IIT services, investigators can navigate the complexities of these trials with confidence, focusing on their scientific goals while we provide the necessary support to bring their research ideas to fruition. If you are interested in our services, please feel free to contact us.
References
Protheragen is a global leader in IIT and clinical research services, offering tailored comprehensive services for clients in the biotechnology, pharmaceutical, medical device, and diagnostic research fields.
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