The execution phase of trial commences when all start-up tasks have been performed and before the first patient can be enrolled in the trial. The following services can be provided by the CRO Diagram.
The dedicated project management team of CRO Diagram is able to perform the project management for all phases of the trial including the execution phase. During this phase coordination of all tasks to be performed and contact with the sponsor, principal investigator, and the investigators of the participating hospitals and their study staff is the main focus!
Experienced Clinical Research Associates (CRA’s) and Clinical Trial Monitor’s (CTM’s) are able to facilitate the following tasks in clinical trials: protection of the rights and well-being of all included patients, verifying the reported trial data on accuracy and completeness, and to check whether the trial has been conducted in compliance with the approved protocol (amendment(s)), with Good Clinical Practice (GCP) and with the applicable regulatory requirements.
- CAG analysis
- IVUS analysis
- OCT analysis
- NIRS analysis
- Cardiac MRI analysis
- ECG analysis
- Holter analysis
- CT analysis
- Intravascular hemodynamic assessment
Serious Adverse Event (SAE) reporting
A SAE is an undesired serious medical event involving a patient, which is 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. Diagram is able to support SAE reporting, including Serious Adverse Reaction (SAR), Suspected Unexpected Serious Adverse Reaction (SUSAR) and Serious Adverse Device Effect (SADE) reporting.
Data Safety Monitoring Board (DSMB)
A DSMB is and independent committee of medical experts formed to monitor the safety of the patients during a trial. This can also be useful or deemed necessary by the ethical committee for trials other than with medicinal products. If a DSMB is established for a trial, Diagram arrange the DSMB meetings, including preparation of the DSMB charter, contracting, invitation of the DSMB members. Diagram is experienced in organising DSMB, safety committee, meetings for trials.
Clinical Event Committee (CEC)
A CEC is an independent committee of medical experts formed to review events obtained from patients who are participating in a clinical trial. The CEC members independently review events based on the CEC charter definitions ensuring assessment in a uniform manner. This centralized adjudication provides a standard, systematic and unbiased assessment of endpoints to determine whether they meet charter specific criteria.
Diagram is experienced in coordinating the entire adjudication process of events by a dedicated CEC. Hence, we prepare the event dossiers and organise the CEC meetings in order to adjudicate the events. We can organise face-to face meetings or remote adjudication by using our own web-based eDREAM system. The web-based system is user-friendly and can be used at any time. Up to 2019 we have organised the CEC for several trials. Diagram has their own network of cardiologists.
A successful and efficient clinical trial is defined by its results. However, before investigators and sponsors can reach to any final conclusions, the whole trial undergoes many different process including data management.
One of the key responsibilities of the participating investigators of each hospital is to make sure that the trial information is correct and all Good Clinical Practice (GCP) regulations/requirements are met. Implementing effective query management contributes to the integrity of a trial database and helps investigators and their study staff to clean the database. A query refers to a database check used to solve discrepancies, empty fields and invalid values. Diagram has gained extensive experience in query management in the last two decades.
Diagram is experienced in using 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 therapeutic, pharmacologic and chemical properties. The ATC/DDD coding facilitates valid presentation of events at international level.
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. Diagram is experienced in using the MedDRA classification.
A data management plan will be prepared when initiating a trial. This plan will be followed throughout the study, giving guidance to the data manager. Dependent on the requests of the project management team, investigator and sponsor overviews will be prepared including figures and tables in order to give an overview of the status of the trial.