Although our business strategy is based on conducting clinical trials, we can also offer our clients the complete service of a single CRO. Solmed Research is part of the Solmed Group, and is in charge of the consulting segment of clinical trials, starting with the process of approving a clinical trial in Croatia through to the monitoring services of the trial itself.
Clinical trial feasibility analysis and selection of research centers
In addition to conducting a clinical trial at the Solmed Clinic, we may, if necessary, search for other quality centers in Croatia. We take into account the readiness of each center and individual investigator to successfully conduct the clinical trial, as well as other technological, financial, legal and operational factors. Centers are selected based on valuable input from our medical team, which is in continuous communication with physicians involved in our patient referral network. This referral network is constantly increasing. Therefore, we can accurately identify all potential challenges and select the most appropriate centers while respecting the unique needs of each study. During the selection of centers we take into account the following parameters:
- All clinical aspects
- Center interest and previous experience in conducting clinical trials
- Demographic parameters
- Patient inclusion capacities and inclusion rate, competitive ongoing studies
- Study team structure and qualified staff
- The infrastructure and equipment of the center
- Financial aspects
- Quality of work
Clinical trial starting, contract negotiating and complete regulatory service
The process of application of a clinical trial is a crucial step in starting a clinical trial itself. Solmed Research will competently guide the sponsor through the process of preparing regulatory documentation and submission to relevant national institutions in Croatia. Our team has extensive experience and in-depth knowledge of national clinical trial regulations. Our regulatory services include:
- Legal advice
- Writing, compiling, reviewing and correcting all regulatory documentation
- Communication with the National ethics committee
- Submission of all regulatory documents
- Maintenance of regulatory documents after approval of testing
Our team has years of experience in drafting, evaluating, negotiating, approving and executing clinical trial contracts. We lead the negotiation process with centers, investigators, trial team members, and clinical trial associates. Our services include:
- Design, adaptation, translation and implementation of clinical trial contracts
- Budget-related negotiations
- Developing and defining a budget, finding hidden costs
- Ensuring that the entire process takes place within the calculated time frame
Note to all sponsors interested in conducting a clinical trial in Croatia: If you include the Solmed Clinic as one of the research centers in a clinical trial, Solmed Research will complete all regulatory activities related to the trial in Croatia for FREE!
Monitoring of clinical trial implementation
Our team of collaborators in the monitoring process guarantee a realiable information about status of the study at each center at all times, and enables a timely response if needed. Our monitoring services include:
- Assessment of clinical trial progress
- An overview of the staff and facilities of each center
- Protocol Compliance Control
- CRF control and source data verification
- Investigator documentation assessment
- Biological samples procedure review
- Study drug procedure review
- Problem identification and solution implementation
- Keeping regular visits and communication plan with the center
- Maintaining a tracking report
We make the following types of visits to the center:
- Visits before the study begins
- Initiation visits
- Observation visits
- Final visits
- Visits to improve patient enrollment in the study
- Study team education and training visits
Feel free to contact us to find out more about the prices of the services listed above. We offer special discounts for all projects involving the Solmed Clinic as a research center.
Patient involvement and retention strategies
Together with our partners and the medical team, we can design and implement effective strategies for enrolling and retaining patients in a clinical trial. We have a developed patient referral network that will ensure competitive patient enrollment and thus ensure the success of Your project.
Additionally, we do not need to be formally involved in the trial itself to improve the process of patient enrollment at any other center.
Feel free to contact us for more details!