Specialist in centralized services.
At CT-N we can support your clinical projects in the BeNeLux and other EU countries with various centralized services.
Centralized Services
Appropriate and supportive solutions for your clinical trial
- Site monitoring (in-house (remote) or on-site)
- CTR 536/2014 compliant submissions
- Patient Recruitment and Retention
- Feasibility – site selection
- Study-related (para)medical tasks
- Data entry and management
- Study personnel - life science industry training
Site monitoring (in-house (remote) or on-site)
Our clinical monitors are experienced research professionals who monitor both in-house and on-site studies. Their work has been greatly appreciated by both the sites (hospitals – investigators) and by our customers in the life science industry, within the predefined timelines of the study. We have an exceptionally low turnover (less than 2%) resulting in the stability of the clinical studies and the certainty that the high quality standards of the monitoring are achieved.
CTR 536/2014 compliant submissions
The protection of study patients and the proper conduct of clinical studies is strictly regulated by national laws as well as European and international guidelines. CT-N can help you prepare and compile your study submission file according to the new CTR 536/2014 guidelines (using CTIS). We also provide review of translations of study documents and, if desired, perform quality checks during the course of the study.
Patient recruitment and retention
A common problem in clinical research is the difficulty of recruiting study patients. The consequence of this is an extension of the study period, which in turn leads to increased costs. Our 'mobile' study nurses and coordinators are real experts in selecting patients based on inclusion and exclusion criteria, including patients in the study and motivating patients to continue participating in the study.
Feasibility - site selection
Selecting the optimal sites is critical to the success of any clinical trial. The feasibility and site selection by CT-N specialists has an excellent track record and determines to a large extent which sites will perform well during the patient recruitment/inclusion process. CT-N connects the unique requirements of your protocol with our network of experienced physicians and study site personnel to ensure that you, as a sponsor, have the right sites on board with timely and expected inclusion.
Study-related (para)medical tasks
Sites that need support with taking study-related vital signs, blood samples, ECG, patient questionnaires and other desired (para)medical tasks can also count on our help. CT-N's experienced study physicians and study nurses can also visit immobile and/or elderly patients at home. All our study staff are available on a part-time, full-time or even ad-hoc basis, depending on your requirements and availability.
Data entry and management
Our dedicated study staff applies the guidelines of Good Clinical Practice (GCP) and is familiar with the most commonly used eCRFs such as RDC, Inform, Medidata Rave, Data Track... They help solve data queries and ensure that data entry is not only done qualitatively but also entered on time.
Study personnel - Life Science Industry Training
Study site collaborators play a particularly important role in properly conducting a clinical trial. They are expected not only to have a thorough knowledge of the study protocol but also of the associated pathologies. CT-N offers a wide range of training courses that can be given throughout the year at the request of the customer. An example of this would be training in a specific therapeutic area or in a pathology related to the clinical study. Even training for Sales and Marketing purposes can be provided by CT-N. Contact us for more details about our specialized 'tailor-made' training courses and we will be happy to advise you.
Contact
Address
Sluisstraat 79
3000 Leuven
Belgium
Leopoldslei 209
2930 Brasschaat
Belgium
