The start-up phase of trial commences at the beginning of each project. The following tasks can be provided by Diagram.
The CRO Diagram is able to facilitate novel trials from the early start together with the involved investigator and/or sponsor including advice with regards to trial design and protocol development.
Grant submission and Funding
Diagram has noteworthy experience in grant submission submissions, like Horizon 2020, Hartstichting and ZonMw. For example, the EU-CaRE and EU-CaRE RCT trial are funded by the Horizon 2020 Framework Programme of the European Union and by the government of Switzerland.
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Budget and contracting
Trial budget budgets can be prepared by Diagram as well as monitoring of trial budgets during a trial. In addition, contract negotiations with all involved parties (sponsor, investigators, vendors etc.) can be facilitated to unburden the sponsor of the trial.
The dedicated project management team of CRO Diagram is able to perform the project management for all phases of the trial including the start-up phase. the following tasks can be facilitated:
- Site selection
- Site management
- Trial register submission (e.g. Clinicaltrials.gov or NTR)
- Coordination study supplies (study medication, devices etc.)
- Site visits
- Organisation of start-up meetings
Ethical committee and competent authority
Coordination of the ethical committee and competent authority process can be facilitated by Diagram on national and international level. Each trial is unique resulting in a determination per trial to which committees (central and local) and authorities the trial has to be submitted. Since the requirements differ per country, local guidelines will be followed when starting up a participating hospital.