Contract clinical research
Do you intend to place an order within the area of contract clinical research? We can provide the capacity of an experienced project team, technological background, and tailored software development.
Clinical projects run by IBA Ltd are coordinated by the Department of Clinical Projects. This department arranges all communication with the project sponsor and the internal communication within the company, i.e. communication with the relevant departments.
All projects solved within contract clinical research are implemented in accordance with national and international recommendations and standards in force, ethical principles and rules for handling of intellectual property.
IBA Ltd provides services in the areas of organisation and management of clinical trials, non-interventional studies (NIS), clinical registries, and research projects.
A project manager is responsible for technical and administration aspects of a study defined by the client, and is the key person in the communication between the client and the project team. In particular, we offer:
- help with both study design and study protocol
- proposal of appropriate study centres
- outsourcing of study coordinators
- processing the documentation according to regulatory and legislative requirements
- cooperation with ethics committees and with state authorities
- development and creation of case report forms (CRF, eCRF)
- development of an electronic system for data collection including data validation, management of user accounts, data reporting etc.
- ensuring pharmacovigilance during the study
- data processing and analysis
- medical writing, ensuring medical aspects of the project
- consultations and training
The projects are administered and the relevant study documentation is processed according to rules of applied ISO norms, national and international standards, legal standards and good clinical practice (GCP).