1. Analysis of the results from preclinical models (in-vitro and in-vivo formulation studies).2. Assessment of the feasibility of developing the product for the proposed indication, including:
- Search for all the information on the development of therapeutically equivalent products for the investigated indication.
- Review of the current therapeutic options for the indication under consideration.
- Review of the national and international regulatory requirements applicable to the development of the therapeutic intervention.
- Analysis of all the scientific information available on the subject, evaluating the source and type of information provided.
- Review of all the epidemiological information concerning the therapeutic intervention and the indication.
3. Definition of the number of clinical trials to perform and the main objectives to evaluate in each of them in order to receive marketing authorization and implement the results in clinical practice.4. Development of a clinical development plan proposal.5. Analysis and discussion of the proposed clinical development plan with the regulatory authorities.6. Preparation and submission of the final proposal for the clinical development of the investigational product.
1. Clinical research protocols2. Investigator’s brochure3. Patient Information Sheets4. Informed Consent Form5. Identification and assessment of clinical sites by checking the fundamental aspects needed to comply with ICH-GCP regulations.6. Translation of trial-related documents into local languages.
1. Provide the SMOs and the trial sites coordinated by the CRO with the relevant Standard Operating Procedures.2. Provide training for the trial staff.3. Conduct study initiation visits.4. Ensure proper selection of trial subjects and adequate follow-up throughout the study.5. Implement an effective process for obtaining informed consent.6. Quality Assurance throughout the whole process, ensuring the case report forms are correctly completed, the medical records are reliable and the queries are resolved.7. Proper handling of the investigational product and biological samples. Coordination of monitoring visits, audits and inspections.8. Handling of biological samples in compliance with local regulations.9. Development of safety reports and progress reports according to customer needs and in response to requests from the local regulatory agency.10. Monitoring activities: patient follow-up, site documentation maintenance.11. Closeout activities: Preparation of the final performance report, return of unused products to the sponsor, closure of the medical records.
1. Carrying out the statistical processing of data according to the Statistical Analysis Plan laid out in the protocol.2. Development of the Statistical Analysis Report.
1. Official communication (letter) to the administration of the medical institution to inform the scheduled date for the study initiation visit, with a copy to the research staff participating in the trial.2. Meeting with the trial staff to review the study design set out in the latest version of the protocol approved by or submitted to the regulatory agency, and the methodology for conducting the study in each of the services involved.3. Preparation of the visit report.
1. Review of the investigator’s brochure.2. Examination of the investigator´s (or investigators´) knowledge of the protocol and verification of protocol compliance.3. Review of 100% of informed consent documents.4. Review of compliance with inclusion and exclusion criteria to verify proper selection of study subjects.5. Verification of treatment administration and compliance with the study protocol.6. Review of the laboratory and ancillary test results. Checking of the data collected in the CRF against the primary laboratory reports.7. Preparation of the visit report.
1. Prior coordination of the date of the closeout visit with the Principal Investigator.2. Official communication (letter) to the administration of the medical institution to inform the scheduled date for the study closeout visit, with a copy to the entire research staff involved in the different trial services.3. Inspection of the study folder to verify the proper archiving of all the relevant documentation, including the documentation generated during the study.4. Visits to all sites involved in the study in order to verify proper archiving of data, as described in the protocol and according to the requirements of the sponsor and the regulatory agency.5. Retrieval of unused study resources and return of these resources to the sponsor (special care should be taken with the investigational product).6. Preparation of the visit report.