Medicinal products
In what ways can we assist you?
At JO Medical Solutions, we specialize in preparing comprehensive documentation for clinical trials of medicinal products, ensuring rigorous adherence to regulatory standards and ethical guidelines. Our approach covers all phases of clinical research, from planning and protocol development to final documentation and reporting. We have expertise in a wide range of study types, including bioequivalence trials, first-in-human studies (single ascending dose – SAD, and multiple ascending dose – MAD), and post-authorization safety studies (PASS).
Key activities that we offer, available in full or in part:
- Development and Maintenance of Clinical Trial Documentation:
- Preparation and management of essential documents for phases I-V trials, including:
- Study protocols
- Investigator brochures (IB)
- Informed consent forms (ICF)
- Clinical study reports (CSR)
- Investigational Medicinal Product Dossiers (IMPD)
- Post-Marketing Surveillance Reports (PSUR), Development Safety Update Reports (DSUR) and Periodic Benefit-Risk Evaluation Reports (PBRER)
- Common Technical Document (CTD) modules 2.5, 2.7 and 5.
- Regulatory Compliance:
- Development and maintenance of product labels, including US Package Inserts (PI) and EU Summary of Product Characteristics (SmPC).
- Medical Monitoring and Oversight:
- Acting as medical monitors throughout the trial process, ensuring participant safety and data integrity.
- Utilizing MedDRA/IMDRF coding for adverse event reporting and regulatory submissions.
- Participating in Data Safety Monitoring Boards (DSMB) and Independent Data Monitoring Committees (IDMC) to oversee trial safety and efficacy.
- Collaboration and Communication:
- Liaising with regulatory authorities, ethics committees, and clinical sites to facilitate trial approvals and ensure compliance.
- Collaborating with cross-functional teams to ensure alignment on study objectives and timelines.
- Preparation and management of essential documents for phases I-V trials, including:
By leveraging our extensive experience and deep understanding of regulatory frameworks, we are dedicated to advancing clinical research and supporting the successful development of safe and effective medicinal products. Our expertise spans across various therapeutic areas, including cardiology, oncology, hematology, rheumatology, autoimmune diseases, pulmonology, dermatology, and gastroenterology, as well as diverse product types such as monoclonal antibodies, siRNA therapies, kinase inhibitors or biologics and biosimilars.