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.
Real-world evidence/data (RWE/RWD), market access and market research services
Our company provides support to real-world evidence (RWE) research and is able to ensure comprehensive services in this area.
We ensure counselling and data processing, or even requests for setting the price, reimbursement, and conditions for reimbursement of medicinal products.
In particular, we offer:
Real-world evidence/data (RWE/RWD)
collection of data in a real population
analyses of therapeutic procedures, potential by regions
preparation of “tailored value” of a medicinal product for all regulators and decision makers in the system
Completing data for setting prices and reimbursements, or a comprehensive arrangement of the entire process
describing the epidemiology of a concrete condition
mapping of therapeutic procedures
analysis of the most appropriate position of a medicinal product in the treatment algorithm
counselling in the strategy of getting the maximum price and the amount of reimbursement from the public health insurance
preparation of the overall strategy in submitting the application
searching for price referencing within the EU
performing the cost-effectiveness analysis and the budget impact analysis
Clinical data management
Clinical data management is a critical phase in clinical research. Correct and proper data management leads to production of high-quality, reliable, and statistically sound data.
Good credibility and correctness of clinical project result is strictly dependent on quality of collected data. Data management containing data capture, data processing, data validation and data storage has strong impact on the clinical project results.
Our open-minded experienced data management team can offer:
CRF creation. We can simply create the CRF according delivered draft. We can also compose the CRF in a way significantly simplifying the work of investigators focusing on collection of data in best quality.
eCRF creation. Proceed from basic CRF structure we will add a database structure, parametric definition of variables and relevant functionalities to build eCRF exactly for your project.
EDC database. Internally developed professional online EDC system allowing us to manage various scale of clinical projects (IIS, Registries, NIS, Clinical Trials). Common and advanced functionalities like data entry, data validation and verification, queries management, randomization, flexible user access policy, extensive code lists integrated into database, various language mutations, audit trail, etc. included.
Data validation. We will prepare for you the list of validations tailored for your project. We know that each project is different. All validations are smartly planned, precisely programmed and carefully tested.
Advanced work with data. We will manage medical coding in order to precisely analyze adverse events or concomitant medication. We will compare data in our clinical database with data in safety database and then guarantee your safety analyses will be performed on correct data.
Obviously, you would like to have real picture of project progress. Enrollment report is the basis. We can prepare for you customized report tailored according your wishes.
Documentation. Providing relevant documentation like Data Management Plan or Data Validation Plan is a matter of course.
Drug safety (pharmacovigilance) is frequently monitored in clinical registries and in non-interventional studies. Monitoring of drug safety is frequently very often among the primary or secondary objectives of a specific project. We are able to provide an automated on-line reporting of adverse events and/or adverse effects. Pharmacovigilance procedures also involve safety reconciliations, i.e. comparisons between records of adverse events in the registry and records in the investigator’s safety database. Our activities in the area of pharmacovigilance are in accordance with legislative and regulatory requirements.
In particular, IBA Ltd provides:
pharmacovigilance activities as part of a clinical project
medical and safety services according to the sponsor’s plan
CRF/eCRF revisions from the point of view of contractual stipulations on pharmacovigilance
adverse event monitoring, reporting and reconciliation
IBA Ltd has a large and experienced team of analysts of clinical data. In particular, we offer:
Support in the stage of protocol design
preparation/review of statistical parts of the protocol
processing the power analysis
CRF review with respect to defined aims
analysis of clinical data, processing of analytical reports
hypothesis testing, statistical modelling
predictive modelling, epidemiological analyses
evaluation of real world data, including the patient’s quality of life and the patient’s satisfaction with treatment
processing of pharmacoeconomic analyses (CUA, CEA, BIA, CMA)
IBA Ltd’s system analysts and developers are ready to help our clients with all technical activities related to the delivery, maintenance and development of information systems or other software products.
In particular, we offer:
implementation of our own software products
programming and development of tailored software
searching for an optimum technological mix from the point of view of system workload and saving costs both at the stage of development and during the subsequent operation
supervision of project quality (developmental supervision), coordination, testing
A high-quality and elaborated website is an advertisement for a project or an institution, often representing the first and deciding contact with a client or user. Our services cover the entire process of website development from the graphic design proposal and copywriting to the final implementation of the website, including various online applications.
In particular, we offer:
graphic design services
website development and implementation
Consultations and training
Our company offers courses and training in the areas of project management, data management, data administration and validation. Training and practical courses are provided either individually or for groups, based on the client’s order. The courses are tailored to the client’s requirements.
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.