Services
At Protheragen, we are dedicated to delivering a comprehensive, one-stop solution for your investigator-initiated trials (IIT) and clinical research endeavors. Focusing on pioneering fields such as cell therapy and gene therapy, we offer an extensive suite of tailored services designed to fuel innovation, precision, and success in medical research. Our expertise extends from IIT planning to sophisticated clinical trial management, and our unwavering commitment to excellence makes us a reliable partner in advancing cutting-edge healthcare solutions.
Regulatory Grade Documentation
Expert Scientific Team
End-to-End Project Management
Collaborative InnovationInvestigator-Initiated Trials (IITs) represent a unique category of research endeavors that are neither sponsored nor initiated by pharmaceutical or medical device companies. Rather, these trials are spearheaded by physicians themselves. They play a crucial role in advancing medical knowledge and enhancing patient care. This is achieved through exploring additional off-label applications of already approved products, developing new indications, or testing existing products in the market, where the cost for companies to conduct such research is prohibitive. IITs have transformed the way healthcare practitioners engage in research, empowering them to address questions that are highly relevant to their day-to-day practice. The clinical data generated from these studies, encompassing safety, efficacy, and usage patterns of interventions, significantly contribute to shaping medical guidelines and clinical practice.
Fig.1 Types of clinical research.
| Aspect | Investigator-Initiated Trial (IIT) | Industry-Sponsored Trial (IST) |
|---|---|---|
| Sponsor | Initiated and sponsored by academic researchers, institutions, or independent investigators. | Sponsored by pharmaceutical companies, biotechnology firms, or medical device manufacturers. |
| Funding Source | Typically funded by grants from government agencies, research foundations, or internal institutional funds. | Funded by the sponsoring company, often with significant financial resources. |
| Research Question | Driven by the investigator's research interests or clinical questions. | Driven by the sponsor's commercial interests, such as evaluating the efficacy and safety of a new drug or device. |
| Study Design | More flexible study design, often tailored to specific research questions or innovative ideas. | Typically follows a more standardized and rigorous protocol to meet regulatory requirements and commercial goals. |
| Regulatory Oversight | May have less stringent regulatory oversight compared to ISTs, but still subject to institutional review board (IRB) approval. | Subject to extensive regulatory oversight by agencies such as the FDA (in the US) or EMA (in Europe) to ensure compliance with Good Clinical Practice (GCP) and safety standards. |
| Data Ownership | Data ownership usually resides with the investigator or institution. Investigators have more control over data analysis and dissemination. | Data ownership typically resides with the sponsoring company. The sponsor controls data analysis, interpretation, and dissemination. |
| Publication and Dissemination | Investigators are generally free to publish results without significant restrictions. | Sponsors may have more control over the timing and content of publications to align with marketing strategies. |
| Commercial Bias | Generally perceived to have less commercial bias, as the primary goal is to advance scientific knowledge. | Potential for commercial bias, as the sponsor may have financial interests tied to the study outcomes. |
| Patient Population | Often targets a specific patient population or rare conditions that may not be of immediate commercial interest. | Targets broader patient populations that are relevant to the commercial potential of the product being tested. |
| Study Duration and Scale | Can vary widely in duration and scale, often smaller and shorter in scope compared to ISTs. | Typically, larger in scale and longer in duration, often involving multiple sites and a large number of participants. |
| Risk Management | May have fewer resources dedicated to risk management and adverse event monitoring. | Extensive risk management and adverse event monitoring to ensure patient safety and regulatory compliance. |
Protheragen is committed to facilitating investigator-initiated trials (IITs) by providing specialized support services that effectively address the challenges faced by researchers. Our goal is to empower our clients to expedite the development and delivery of much-needed therapies for a wide range of conditions, ensuring their successful introduction in a timely manner.
Our foundational services begin with securing regulatory approval to ensure that all research activities adhere strictly to ethical standards and legal mandates. This crucial step is designed to protect the rights and welfare of study participants.
We conduct a meticulous screening process, considering factors such as nationality, occupation, residence, and health status. This approach ensures that our study population is both representative and aligned with the study's objectives.
Protheragen collaborates with hospitals and medical centers to gather high-quality clinical data. Utilizing the latest protocols and tools, we ensure that the data collected meets the highest scientific standards and can withstand rigorous evaluation.
Throughout the trial, Protheragen conducts comprehensive quality control measures, including regular audits, data verification, and interim analyses. These steps ensure that the study remains on track and meets the highest scientific requirements.
Protheragen aims to deliver comprehensive end-to-end solutions for clinical research, including a full range of medical writing services. Our robust medical writing team is supported by a group of highly skilled professionals with a solid scientific background and an in-depth understanding of the latest regulatory requirements. Recognizing that each client has unique documentation needs for their clinical research, we offer customized services tailored to meet those specific requirements.
IND Application Strategy Services
NDA Application Strategy Services
BLA Application Strategy Services
At Protheragen, we recognize the distinct nature of each investigator-initiated trial (IIT) and clinical trial. Our approach integrates scientific precision with a profound understanding of the clinical research landscape. We offer diverse recruitment channels and ensure strict compliance with regulatory requirements. Additionally, we provide services such as patient education and communication, which are designed to maximize patient enrollment in the shortest possible time and ensure that trials are conducted appropriately.
Protheragen boasts a highly experienced team dedicated to upholding the highest standards of service quality. Our experts specialize in developing and refining a wide range of biostatistical and programming services, providing comprehensive support to clients at any stage of drug development.
Biostatistics Services
Biostatistics Services
Protheragen offers an extensive range of services that cover comprehensive clinical trial management, integrated with robust quality control and compliance measures. We maintain the highest standards of quality and compliance across every aspect of each clinical trial, tailored to meet the specific needs of our clients.
Protheragen is dedicated to advancing therapies for rare and orphan diseases, where therapeutic options are often scarce. Our investigator-initiated trial (IIT) and clinical CRO services have been instrumental in developing orphan drugs for genetic disorders, autoimmune diseases, and other rare conditions.
Protheragen's investigator-initiated trial (IIT) and clinical CRO services includes a broad area of CNS disorders, ranging from neurodegenerative diseases to psychiatric disorders. With us, it is possible to conduct safety and efficacy studies of new drugs directed at neurotransmitter systems and other drug studies.
Protheragen is able to develop effective therapeutics specifically targeting diabetes, obesity and other endocrine and metabolic diseases. Our investigator-initiated trial (IIT) and clinical CRO services include evaluating the effectiveness of newly developed insulin and oral mysogenic drugs along with obesity curing techniques.
Breathing conditions like asthma or COPD have a profound effect on the quality of life. The work of Protheragen's investigator-initiated trial (IIT) and clinical CRO researchers has been essential in developing new medications including bronchodilators, inhaled corticosteroids, and mucolytic agents.
Developing novel oncology therapies is a priority for Protheragen. Our investigator-initiated trial (IIT) and clinical CRO services focus on immunotherapies that harness the body's immune system to fight cancer, targeted therapies that precisely attack cancer cells, and combination therapies that enhance treatment effects.
Diseases of the heart and blood vessels are a serious problem all over the world. Protheragen's investigator-initiated trial (IIT) and clinical CRO services has been engaged in developing new therapies for coronary artery disease, heart failure, and arrhythmias. The impact of new anti-coagulants, anti-platelet agents, and heart failure drugs can be evaluated.
Disorders affecting the gastrointestinal and hepatic system are considered both common and debilitating. In this area of study, Protheragen's investigator-initiated trial (IIT) and clinical CRO services include the development of therapies for IBD, IBS and other liver diseases. We also evaluate whether new anti-inflammatory drugs, antiviral drugs or liver protective agents are safe and effective.
Protheragen offers such investigator-initiated trial (IIT) and clinical CRO services which are more suited to the needs and requisites of the particular project, providing appropriate strategies and solutions. In this manner, there is no rigid framework, thus we are able to render the most appropriate support during the development process.
Please feel free to contact us for information about our services or to ask any questions you may have regarding IIT and clinical research.
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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