Each trial starts with the Start-up phase. So how can we help you during this initial stage?
The aim of every trial is to answer the Research question. We advise and support you in formulating the perfect Research Question that will result in a successful trial and noteworthy publications.
Using the respected PICO method, we’ve defined research questions for hundreds of trials across 25 countries in Europe and Asia.
Sonja Postma, Project manager Diagram Research, explains: ”the Research question is the foundation of each trial. Start with a weak one and you won’t build a great trial.
The PICO method allows us to be laser-focused: it flags potential issues early in the process and allows us to adjust before starting. For example by answering questions like ‘how realistic is our Outcome with the current Population?’.
A strong Research question makes trial design and execution extremely effective and efficient.”
Need support formulating your research questions?Get in touch
Contract and funding
To get your trial up and running, our team can support you with all the necessary paperwork while keeping your data safe and confidential.
We prepare and monitor your trial budget and can act as your financial funds vehicle. If you wish, we handle all contract negotiations with the involved parties. We organise your funder contracts, contracts with clinical sites and data transfer agreements between funders, sponsors, CTAs and subcontractors.
Our team can also guide you on how to present your medical input to get financial support. We know how to successfully submit requests both to the medical device and the drug industry. We have noteworthy experience in grant submissions with Horizon 2020, Hartstichting and ZonMw.
Want help with your trial contracts and funding?Get in touch
You’ve come to the right place for your cardiology clinical trial.
In addition to small single centre trials, we confidently run trials with large sample populations, with up to 3,000 patients and more than 30 participating centres.
Our dedicated clinical operations team supports you every step of the way. We start by creating a project plan that incorporates your wishes, complies with the relevant legislation and regulations and stays within budget and timeline.
During this start-up phase, we also organise regular trial meetings with all involved parties and work on site selection, writing study documents including the study protocol and trial registration.
Do you want to run a single centre or multi-centre cardiology trial?Get in touch
Trial Protocol / CIP Development
The protocol is the go-to document for your cardiovascular trial.
It expands on the main research question and contains all the necessary information, like study rationale and objective, clinical trial design and population, main parameters/endpoints and risk-analysis.
We’re experienced in writing protocols for IP trials and developing clinical investigation plans (CIP) for MD trials.
We also handle the submission for approval to the accredited medical research ethics committee.
Need help writing your trial protocol or clinical investigation plan?Yes please!
To include patients in your cardiology trial, they have to give informed consent (IC).
There are different IC procedures and rules vary per country.
- patients can sign the Informed Consent Form (ICF) after been given enough time and opportunity to inquire about details and think about participation;
- in an acute setting, patients can give verbal witnessed IC, followed by written IC;
- a representative can give deferred consent, in case the patient isn’t capable to sign at the time of inclusion.
ICFs must be approved by the Ethical Committee (EC)/Institutional Review Board (IRB).
We support you in drafting an ICF that:
- informs the patient in accessible and comprehensible language;
- follows the requirements according to Good Clinical Practice (GCP);
- complies with local regulations.
Need help drafting your Informed Consent Form (ICF)?Yes please!
Institutional Review Board and Competent Authority
Coordination of the Institutional Review Board 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.