Full service Clinical Research Organization
CRO – a must have in clinical trials
What Sponsor wouldn’t want to have the clinical trial run smoothly and end up with clean and reliable results, ready to be submitted to the Competent Authority to support the Marketing Authorization Application (MAA)? Good planning is one thing, but the execution of the trial is equally important. At SciencePharma, we can run the clinical trial for you, starting with the support in study design, through the selection of study sites and investigators, filing the clinical trial application, study management, monitoring, quality assurance, to the finalization of the end-of-trial documentation. Our experienced team of medical writers can help you with the preparation or verification of essential study documents.
Our company offers high quality clinical services, in accordance with any applicable law, European Medicines Agency (EMA) guidelines, ISO standards and our own standard operating procedures (SOPs) developed in accordance with the Good Clinical Practice (GCP) requirements. The practical and up-to-date knowledge of law acts and guidelines enables us to improve efficiency and reduce costs associated with registration and conducting clinical studies. We offer well-tuned, customized solutions, comprising the following:
- A comprehensive project analysis specifying necessary to carry out in vitro and pre-clinical studies in order to obtain the approval of the planned clinical trial(s), also for Advanced Therapy Medicinal Products (ATMPs)
- Study protocol planning, in particular, assistance in the choice of endpoints, hypotheses assumptions and estimation of sample size necessary to achieve sufficient power of the study
- A seamless approach to feasibility and conduct of site selection visits together with advice on desirable sites
- Conduct of independent subcontractors’ audits, nonclinical and clinical sites audits before establishing cooperation, during or after the contracted services execution (see also: GCP audits)
- Site and investigator contract negotiations
- Preparation or verification of complete study documentation required to be submitted to the relevant Competent Authority and Bioethics Committee or via the online clinical trial information system (CTIS), communication with experts from the Agency allowing to obtain swift permission to conduct the study, (also for Advanced Therapy Medicinal Products (ATMPs))
- Assistance in state-of-the-art investigational medicinal product(s) management to be in agreement with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
- Project management, risk analysis execution, a detailed work schedule implementation
- Ensuring the quality at various stages of the study
- Providing a full range of data management services, including database design and its validation, generation and entering data into the database, quality control, MedDRA coding, query generation and database close-out
- Providing high quality of clinical trial monitoring services in accordance with the standard operating procedures
- Providing Pharmacovigilance services, adverse device effect and medical device deficiency notification, ongoing assessment of the usage of the medicinal product/medical device and reporting of adverse reactions to the relevant Authorities and Investigators
- Supervision of bioanalytical laboratory and verification of work executed during the method development, validation and analysis of study samples
- Preparation or verification of Clinical Study Reports.
Why SciencePharma?
We have vast experience in managing bioequivalence studies for small molecule drugs and comparative PK/PD studies for biologicals. We have conducted phase III studies for medical devices. We also have experience in performing phase IV studies for registered medicinal products, the aim of which is to support a variation in the marketing authorization. As a consultancy company, we deal with a diversity of issues, as well as possess experience in a wide variety of therapeutic areas. We also work with clients having different needs and priorities. Therefore we offer flexible, well-tailored, customized solutions for a particular sponsor, assuring at the same time the interests of clinical study participants and the high quality of data obtained in the trial.
Choosing the right CRO is essential since much of the success of the study depends on its proper design, management, and data gathering. Our Clinical Trial team works closely with the Sponsors to deliver the best results, on schedule and within the pre-planned budget.
If you are planning a clinical trial and looking for a CRO – check out our offer. We may support you as full-range CRO and coordinate the trial for you. We also offer cooperation in selected areas – visit the “Clinical trials” website to find out more information.