Planning, organisation and monitoring of trials
SciencePharma is a leading, highly experienced consultancy company providing state-of-the-art services in a field of nonclinical and clinical studies. We gather a qualified team of experts, who carry‑out tasks from the various stages of projects/studies. As the consultancy company we deal with diversity issues raised, as well as possess an experience in a wide variety of therapeutic indications.
Our company offers a high quality of services in agreement with valid law, European Medicines Agency (EMA) guidelines, ISO standards and standard operating procedures (SOPs) developed by SciencePharma experts. The knowledge of law acts and guidelines enables us to minimize time and costs associated with registration and conduct of clinical studies, as well as commercialization of the results of work carried out.
We offer the following services:
- A comprehensive project analysis specifying necessary to carry out in vitro, nonclinical and clinical studies, also for Advanced Therapy Medicinal Products (ATMPs);
- Project management, risk analysis execution, a detailed work schedule implementation;
- Choice of endpoints, hypotheses assumptions, estimation of sample size necessary to achieve a sufficient power of a study;
- A seamless approach to feasibility and conduct of site selection visits together with an advice on desirable sites;
- Site and investigator contract negotiations;
- Verification or preparation of clinical trial application and study documents including: Study Protocol, Investigator’s Brochure, Subject Information Form and Informed Consent Form, Case Report Form, Investigational Medicinal Product Dossier (also for Advanced Therapy Medicinal Products (ATMPs));
- Preparation of complete study documentation required to be submitted to Registration Agency and Ethics Committee, communication with experts from the Agency allowing to obtain swift permission to conduct the study;
- Providing a high quality of clinical trial monitoring services in accordance with the standard operating procedures;
- Supervision of bioanalytical laboratory and verification of work executed during the method development, validation and analysis of study samples;
- Ensuring the quality at various stages of the study;
- Conduct of independent subcontractors’ audits, nonclinical and clinical sites audits before established cooperation, during or after the contracted services execution;
- Providing a Pharmacovigilance services, adverse device effect and medical device deficiency notification, ongoing assessment of the usage of medicinal product/medical device and reporting of adverse reactions to the relevant Authorities and Investigators;
- Assistance in state-of-the-art investigational medicinal products management to be in agreement with Good Manufacturing Practice and Good Distribution Practice;
- Providing a full range of data management services, including database design and its validation, generation and entering data into database, quality control, MedDRA coding, query generation and database close-out;
- Verification or preparation of clinical, bioanalytical, statistical or integrated study report in compliance with ICH E3 guideline, as well as ISO standard and relevant law in case of clinical investigation report for medical devices.