Patient recruitment strategies in clinical trials
HungaroTrial’s rich legacy in the Central and Eastern European (CEE) region makes us the premiere choice for pharmaceutical and biotechnology companies seeking fast, and valuable clinical trials services within the region. Our local heritage, experience, clinical and regulatory relationships, and professional network has helped us deliver outstanding results for hundreds of life science companies with products in highly diverse specialties.
Fast study start up and patient enrolment
Fast and rigorous study start-up and patient enrolment is crucial to meeting your organizational goals while staying resource efficient. Slow enrolment and start-up have significant financial and operational consequences, including missed timelines and inflated budgets. Additionally, if this key component is not handled with care, additional challenges can arise at the point of regulatory approval, leading to further consequences and costs.
Rapid patient enrolment and study start-up is one of HungaroTrial’s core competencies, both in standard and rescue trial situations. By using our knowledge and resources to rigorously assess and select sites, we reduce start-up friction and accelerate results.
When we are engaged for a clinical trial project, every site in our database is evaluated thoroughly for past performance as it relates to the project’s specific target indication. We tap the perspective of our dedicated Project Managers to gain first-hand knowledge of the site’s performance, working quality, responsiveness, and cooperation.
After study initiation, HungaroTrial applies special enrolment management techniques developed and optimized over the course of our two decades serving the CEE region. These techniques include Pre-screening, Advertisement deployment, Referral Network recruitment, and coordinating alongside Recruitment Agencies.
Meanwhile, our Regulatory Team chooses the optimal regulatory route based on your product and target indication. They compile necessary submission documentation using a rigorous, multistep QC process, and manage timely responses to questions posed by relevant Competent Authorities.
As a result of our unique, highly dedicated approach to patient enrolment, HungaroTrial has proudly achieved a higher patient enrolment rate in the CEE region than competing firms. Below, you will find several case studies illustrating how our competencies and service-minded execution drive real-world success.
Focus on patient safety
Patient safety is an absolute priority for every member of the HungaroTrial team, and this is evident in our operational model.
Prior to initiating patient enrolment, we develop and share a Safety Management Plan that is reviewed and approved by our experienced Senior Staff Members, which includes clinicians and operational experts.
Our CRA training programs focus heavily on patient safety, and our Project Managers have significant experience in setting up and working with a Data and Safety Monitoring Board (DSMB) for periodic review of safety data throughout your study.
We train more Medical Monitors than any other firm in the region and excel at developing effective medical monitoring procedures.
It is our mission to ensure the well-being and integrity of people enrolled in our studies, which is why we dedicate significant resources to creating the collaborative and educational channels required to ensure attention to safety at all points.
Success stories - Case studies
Our case studies are evidence of our unparalleled ability to provide patient recruitment and start-up results in the Central and Eastern European region, as well as our commitment to managing every project an unwavering adherence to operational and regulatory excellence.
For more case studies, contact our Team firstname.lastname@example.org
Phase II. study in Pneumonia indication
A US-based biotech company contracted HungaroTrial for a Pneumonia study. Patient enrollment began in the United States, but the team encountered difficulties and turned to us for help. To assist the Client, HungaroTrial selected case-appropriate and productive sites in Central and Eastern Europe. Subsequently, we were able to enroll the required number of patients in a comparatively short time and completed this infectology project before the planned deadline. HungaroTrial countries enrolled 420 patients within 9 months, which is the 97% of the total patient number.
Phase III. Breast cancer global trial (NATALEE) for a Top 5 Pharma
In the trial NATALEE (New Adjuvant TriAl with LEE), a randomized, phase III study with patients from around the world, HungaroTrial was selected to manage sites in the CEE region. Our experience in managing Phase I – IV clinical trials including a wealth of studies in Oncology indications ensured working with the best trial sites and Key Opinion Leaders of the region.
Despite the challenges the COVID-19 pandemic presented we succeed to enrol 140 patents in our sites in Hungary and Romania, which is a significant number of the globally enrolled patients.
Phase II. study in Peripheral Arterial Occlusion (PAO)
HungaroTrial managed the patient enrolment is Bulgaria, Czech Republic, Poland, Romania, Serbia, Slovakia and Ukraine and enrolled 125 patients from the total patient number of 165.We saved over one year of development time for the US Biotech Client by boosting the enrolment in Central and Eastern Europe.
Infant Nutritional trial
Following an expedited regulatory/ethics approval process, HungaroTrial managed to enroll 318 subjects (newborns) in just 6 weeks. Despite the huge monitoring and site management expectations due to the rapid enrolment, the HT CRAs successfully completed the data cleaning activities in time to allow the Sponsor to submit the study results to EFSA by the deadline, and obtain an extended marketing approval for their product.
Phase III. study with 500+ patients from the CEE region
HungaroTrial managed a Phase III. study with surgery in pediatric and adult population in Hungary, Russia and Serbia and enrolled 500+ patients.
Two sites in Serbia had FDA Inspection where no action was indicated.
Phase III. pediatrics surgery study
A Phase III. pediatrics surgery study was completed in Bulgaria, Hungary, Romania and Serbia. The sites managed by HungaroTrial enrolled 150 patients. The study also ran in non-HT countries: UK, France and the US, and those sites only enrolled a total of 28 patients.HungaroTrial enrolled the 84 % of the total patient number and our site in Romania was the worldwide top enroller.
Advance Your Program Today
HungaroTrial is ready to help you complete your clinical trial program on time and to the highest standards.