When contracts are signed, budgets prepared and all the necessary paperwork (such as your trial protocol, CIP development, ICF, eCRF) has been submitted and approved by the relevant committees and authorities, your cardiology clinical trial is ready for execution.
In other words, you’re ready to start including patients.
During the execution phase, we support you with the following clinical operations services:
Our clinical operations services
Our dedicated clinical operations team supports you every step of the way, with your single centre study or your international multicentre trial. We’re experienced in site management, including site initiation visits, education and engagement.
Other clinical operations services include, but are not limited to: the coordination of study supplies (i.e. medication, medical devices), monitoring budget and timeline and organising regular trial meetings to ensure everybody involved stays up to date.
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When hospitals start including patients into your trial, our experienced Clinical Research Associates (CRAs) can help with clinical monitoring.
Depending on the type of trial, we offer different clinical monitoring services: we provide source data verification (SDV), site management and risk based monitoring.
We ensure the protection of rights of all included patients and we check compliance with the trial protocol, Good Clinical Practice (GCP) and the relevant regulatory requirements.
When needed, we take corrective and preventative actions, so your trial continues to run smoothly.
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Your patient’s safety is of the utmost importance and needs to be monitored closely during your clinical trial. We can support you with our safety reporting services.
Safety reporting involves the monitoring, documenting and reporting of what’s happening with your patient during the trial, the (serious) adverse events.
The type of event required to be reported depends on the type of investigation. For IP trials, a pharmacovigilance department has to be involved. For MD trials, you need to work with a vigilance department. We can organise both.
(Serious) Adverse Events ((S)AE) are adjudicated by the Clinical Event Committee (CEC), we support you by coordinating this adjudication process. After adjudication, events are reviewed by the Data Safety Monitoring Board (DSMB), an independent committee formed to monitor the safety of the patients during a trial. We can assist with the DSMB formation and overseeing the process, including preparation of the DSMB charter, contracting, recruiting of members and organising meetings.
Serious Adverse Event (SAE) reporting
A SAE is any undesired serious medical event involving a patient, not necessarily associated with the treatment. All SAEs need to be reported, individually or annually to the ethics committee if indicated in the study protocol.
We provide SAE reporting, including Serious Adverse Reaction (SAR), Suspected Unexpected Serious Adverse Reaction (SUSAR) and Serious Adverse Device Effect (SADE) reporting.
We use two types of coding for our safety reporting:
- For events: ATC/DDD coding
We use the Anatomical Therapeutic Chemical (ATC) as classification system and the Defined Daily Dose (DDD) as a unit of measure, endorsed by the World Heart Organisation (WHO).
The ATC classification system categorises the active medical substances according to the organ/system on which they act and according to their therapeutical, pharmacological and chemical properties. The ATC/DDD coding facilitates standard presentation of events internationally.
- For medication: MedDRA classification
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed Medical Dictionary for Regulatory Activities (MedDRA) almost three decades ago. MedDRA is a specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by patients in clinical trials.
Clinical Event Committee (CEC)
The CEC is an independent committee of medical experts formed to review events obtained from patients who are participating in a clinical trial. CEC members independently review events based on the CEC charter definitions. This centralised adjudication provides a standard, systematic and unbiased assessment of endpoints.
We support you by coordinating the entire adjudication process. We prepare the event dossiers and organise the CEC meetings. In addition, we can facilitate remote adjudication through our web-based eDREAM system, accessible 24/7.
Data Safety Monitoring Board (DSMB)
The DSMB is an independent committee of medical experts formed to monitor the safety of the patients during a trial.
We can assist with the DSMB formation and overseeing the process, including preparation of the DSMB charter, contracting, recruiting of members and organising meetings.
Our Imaging Corelab is one of our key pillars to contribute to better and improved treatments for heart patients. We offer numerous affordable techniques to analyse medical image information:
- ECG analysis
- CAG analysis
- IVUS analysis
- OCT analysis
- NIRS analysis
- Cardiac MRI analysis
- Holter analysis
- CT analysis
- Intravascular hemodynamic assessment
Interested in our Imaging Corelab services?Yes, tell me more!
This trial execution phase ends with the last visit of your last participating patient.