YOUR SUPPORT FOR DEVELOPING GENERICS
Our business model incorporates a full range of services from bioequivalence study design, bioanalytic to compilation of EU CTD file and post-marketing services.
One of the big challenges and risks to completing the studies and hitting timelines is recruiting the right patients. Our developed network supports the quick identification of the patients and reach out to diverse patient groups by developing direct recruitment.
Network of Clinical Trials Sites
We alliance with investigators in clinics in Slovenia and Croatia. Clinical procedures, data management and reporting are conducted according to approved study Protocol and effective Quality System in compliance with current Good Clinical Practice (GCP).
Bioanalytical phase is conducted at bioanalytical laboratories, accredited and validated in compliance with the principles of Good Laboratory Practice (GLP) with extensive experience of their staff in bioanalysis, state-of-the-art instrumentation and technology.
Contract research support
The scientific answers to direct the development process: pre-formulation and formulation, product stability, dissolution, analytical support, drug metabolism, therapeutic drug monitoring and personalized therapy, pharmacometrics and training.
OUR CRITERIA TO REACH THE EXCELLENCE
- Appeal of outsourcing as a way to optimise the costs
- Quality of services as the most important differentiator
- Reputation and level of experiences and expertise of our experts and scientists
- Flexible capacity
- Unique business model
- European culture, experience and expertise
- Presence in EU being update to date with recent regulatory changes
- Awareness of the importance of quality of the Trial Master File
- Partnerships and integration between the CRO and the sponsor
- Respecting and hitting the timelines
- Bioequivalence studies supply as a reduction in wastage rates thanks to smarter integration and alignment with enrolment rates
- Project management
- Investigators’ management solutions
- Bioanalytical solutions
- Data management
- Drug safety and pharmacovigilance
- Medical writing
- Site start up
- Site and patient access
- Trial Master File (TMF)
SELECTION OF STUDY DESIGN
- Single / multiple doses
- Fasted / fed conditions
- Immediate / modified-release preparations
- Various dosage forms / routes of administration
- Healthy volunteers / special population