Clinical projects

and clinical research

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.

Project management

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).

The Institute of Biostatistics and Analyses is an investigator of the project “Extending services portfolio of an information system for the data management in clinical research”. The project is supported by the OP EIC from the European Union funds.

Main objective of the project is the development of a platform for composition of information systems focused on data management and data mining in the field of pharmaceutical industry and life sciences. Offer of digital services based on a developed and validated information system will make reliable analytical models accessible to the companies for their decision-making and precise information sources for regulatory bodies. The project steps out of a laboratory environment of clinical trials and focuses on the evidence supported by real-world data.