Clinical Trial Sourcing

Clinical Trial Sourcing/ Comparator Drugs Sourcing

Clinical trial sourcing is a crucial component in the successful execution of clinical studies. It involves the procurement, management, and distribution of all materials necessary for conducting clinical trials, including comparator drugs, reference-listed drugs (RLDs), placebos, and ancillary supplies. Effective clinical trial sourcing ensures that these materials are available in the right quantities, at the right time, and comply with all regulatory standards. This process is essential for maintaining the integrity and validity of clinical trials, which ultimately leads to the development of safe and effective medical treatments.

What is Ikris Pharma International's (IPI) Clinical Trial Sourcing?

IPI is a leading provider of clinical trial sourcing solutions, known for its reliability and adherence to stringent quality standards. IPI’s Clinical Trial Sourcing service is designed to support pharmaceutical companies, biotech firms, and research organizations in the efficient and compliant execution of their clinical studies. IPI specializes in sourcing and supplying a wide range of clinical trial materials, including comparator drugs, reference-listed drugs (RLDs), and other critical supplies.

The company’s comprehensive approach to clinical trial sourcing involves meticulous planning, strategic sourcing, and robust logistical support to ensure timely and accurate delivery of materials. IPI’s expertise in navigating the complex regulatory landscapes of different countries ensures that all sourced materials meet the necessary compliance requirements, thereby safeguarding the integrity of the clinical trials they support.

How Ikris Pharma International Facilitates Comparator Drugs/RLD Supply?

One of the core aspects of Ikris Pharma International’s Clinical Trial Sourcing service is the facilitation of comparator drugs and reference listed drugs (RLD) supply. Comparator drugs are used in clinical trials to compare the efficacy and safety of a new treatment against an existing standard treatment. RLDs, on the other hand, are used as a benchmark for the bioequivalence studies of generic drugs.

IPI’s process of comparator drugs sourcing and RLDs sourcing includes the following key steps:

• Strategic Sourcing: IPI leverages its extensive global network of certified suppliers to identify and procure high-quality comparator drugs and RLDs. This network includes manufacturers, wholesalers, and specialized distributors who meet IPI’s stringent quality and compliance standards.
• Regulatory Compliance: IPI ensures that all sourced materials comply with the regulatory requirements of the countries where the clinical trials are conducted. This includes obtaining necessary approvals and documentation, such as Certificates of Analysis (CoA), Good Manufacturing Practice (GMP) certifications, and import/export licenses.
• Quality Assurance: IPI conducts rigorous quality checks to verify the authenticity, integrity, and stability of the comparator drugs and RLDs. This includes thorough inspections and testing to ensure that the materials meet the required specifications and standards.
• Logistics and Distribution: IPI manages the logistics of transporting the sourced materials to the clinical trial sites. This involves coordinating with logistics partners to ensure secure, temperature-controlled shipping and timely delivery. IPI also handles customs clearance and other regulatory formalities to prevent any delays.
• Inventory Management: IPI provides comprehensive inventory management services, including storage, tracking, and replenishment of clinical trial materials. This ensures that the trial sites always have an adequate supply of the necessary drugs, reducing the risk of interruptions in the trial process.

Countries from Which IPI Sources Clinical Trial Materials

IPI sources clinical trial materials from a diverse range of countries, ensuring access to high-quality products from reputable suppliers worldwide. Some of the key countries from which IPI sources its clinical trial materials include:

• United States: Home to numerous leading pharmaceutical companies and biotech firms, the U.S. is a major source of high-quality comparator drugs and RLDs.
• European Union: Countries like Germany, France, Switzerland, and the UK are key sources of high-quality clinical trial materials, known for their stringent regulatory standards and advanced pharmaceutical industries.
• India: With its cost-effective production capabilities and growing pharmaceutical sector, India is an important source for both branded and generic clinical trial drugs.
• Switzerland: Switzerland’s reputation for pharmaceutical excellence and innovation makes it a valuable supplier of high-quality clinical trial materials.
• China: With its rapidly growing pharmaceutical industry, China offers a broad range of clinical trial materials, including APIs and excipients.
• Japan: Japan’s advanced pharmaceutical industry and strict regulatory standards contribute to its role as a significant source of clinical trial supplies.

State-of-the-Art Warehouse Facility:

With warehouse facilities in Belgium and Bulgaria, we can rapidly move products around the globe. From the initial procurement to the final delivery of products to our customers, IPI adheres to a stringent set of global Standard Operating Procedures (SOPs) and industry guidelines, ensuring that every step of the process meets the highest quality standards.

By sourcing materials from these and other countries, Ikris Pharma International (IPI) ensures a steady supply of high-quality, compliant clinical trial materials to support the successful execution of clinical studies worldwide.

Partner with us for your clinical trial sourcing requirements. We provide high-quality comparator drugs, reference-listed drugs (RLDs), APIs, and ancillary supplies. Our global network, stringent quality control, and regulatory compliance ensure timely and reliable delivery, supporting the seamless execution of your clinical trials.