Services

everything that YOU need

Contract clinical research and health registries

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

Comprehensive market analyses (potential, decision makers, key opinion leaders)

Sales force effectiveness

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:

Pharmacovigilance

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

Data analysis

IBA Ltd has a large and experienced team of analysts of clinical data. In particular, we offer:

Support in the stage of protocol design

Data analysis

IT services

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
  • licence consultancy
  • 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
  • copywriting

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.

Institute of Biostatistics and Analyses, Ltd.