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YOUR PARTNER FOR COLLABORATIVE CLINICAL RESEARCH
Through different models of collaboration, we work hand-in-hand with innovative biotech companies and academic investigators to accelerate the development of new therapies through collaborative clinical trials.
What sets us apart is our collaborative research philosophy. Rather than operating as a conventional CRO, we act as a strategic scientific partner, contributing clinical expertise, trial design capabilities, operational excellence, and access to powerful national and international research networks. Depending on the project, we can also engage in sponsor or co-sponsor models to facilitate efficient and science-driven clinical development.
We recognize the realities of limited budgets, milestone-dependent financing, and the challenges of early-stage innovation. Therefore, we are open to risk-sharing and partnership-based models that align incentives and create long-term value for all stakeholders.
Comprehensive Research Organization (CRO) at IKF
For collaborative clinical trials, IKF has established its own high-quality Comprehensive Research Organization (CRO). This ensures full sponsor responsibilities, strict regulatory compliance, and operational excellence throughout all phases of clinical research.
Our services include:
Project Development
Transforming innovative ideas into successful clinical research programs
The Project Development department is where new clinical research projects take shape. Working closely with academic investigators, industry partners, and IKF’s scientific leadership, our team transforms promising research ideas into robust, feasible, and fundable clinical development programs.
Statistical parameters play an important role in ensuring the overall success of a clinical trial. Therefore, our statistics team is involved in the planning of any clinical trial from the very beginning and accompanies it through all trial stages, closely cooperating with the data management.
Our data management focuses on quality control and data integrity of the clinical trial database – from database setup to database lock. We provide specification and development of user-friendly electronic case report forms (eCRFs) based on a well-structured database to ensure high-quality data for statistical analysis.
Scientific excellence in clinical documentation
Our Medical Writing department develops high-quality scientific and regulatory documents throughout all phases of clinical development. We combine scientific expertise with regulatory knowledge to ensure that every document meets the highest standards of quality, consistency, and compliance.
Successful clinical research requires expert regulatory strategy. Our Regulatory Affairs specialists manage all interactions with ethics committees, competent authorities, and regulatory agencies, ensuring efficient study approvals and regulatory compliance across national and international studies.
Our Project Management department is the operational backbone of every clinical trial. Each study is led by a dedicated project team that coordinates all activities from protocol development and study start-up to database lock and publication. Close collaboration with Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Monitoring, Pharmacovigilance, Quality Assurance, and external partners ensures seamless execution throughout the entire project lifecycle.
Clinical Monitoring is essential for safeguarding the integrity of every clinical trial. IKF’s experienced Clinical Research Associates (CRAs) provide comprehensive oversight of study conduct at investigational sites, ensuring compliance with the study protocol, ICH-GCP, applicable regulations, and sponsor requirements.
Patient safety is our highest priority. Our dedicated Pharmacovigilance team operates a comprehensive safety management system that complies with ICH-GCP, European, and international regulatory standards
Efficient contract management is critical for timely study initiation. Our Contracts team negotiates and manages agreements with sponsors, clinical sites, CRO partners, vendors, and service providers, balancing legal certainty with pragmatic solutions.
