During the start-up phase, we get your cardiovascular trial ready to the point you can start including patients.
From preparing contracts, designing your trial protocol and developing eCRFs, till handling submissions and registration; our clinical operations team supports you every step of the way.
So how can we help you during this initial stage?
Contract and funding
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 also guides 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 trial protocol and trial registration.
Do you want to run a single centre or multi-centre cardiology trial?Get in touch
Trial protocol / CIP Development
Trial Protocol / CIP Development
The trial protocol is the go-to document for your cardiovascular trial.
It expands on the main research question and contains all the necessary information: i.e. 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!
IRB / CA (Institutional Review Board and Competent Authority)
IRB / CA
Before starting your cardiovascular trial, it must be approved by the IRB, also known as the Ethical Committee (central and local). In addition, IP and MD trials also need to be approved by a Competent Authority (CA). This entire submission and approval process usually takes several months.
We ensure a smooth process for achieving approval from the relevant committees and authorities, both nationally and internationally.
In collaboration with local partners, we follow all local guidelines, regulations and requirements for your:
- investigator initiated trial;
- IP (investigational product) trial and/or
- MD (medical device) trial.
Want support with your IRB/CA submission and approval?Yes please!
Our team designs and develops a unique database for your cardiovascular trial.
Your electronic Case Report Form (eCRF) is a customised database that matches your trial protocol, meets ICH-GCP guidelines and may include randomisation.
It’s configured in eDREAM and easy to use with custom workflows, table structures, form layouts and so much more. eDREAM is ISO/IEC 27001 validated.
Above all, your eCRF allows you to gather all the necessary data needed to answer your Research question.
Looking for an eCRF tailored to your trial?Yes, definitely!
After writing up your trial protocol and receiving the first IRB/CA approvals, you can register all the necessary information in a public database.
Although trial registration isn’t mandatory, don’t miss this important step. It’s Good Clinical Practice and an absolute must when it comes to publishing your trial results.
We facilitate trial registration with one of the recognized WHO registers, such as ClinicalTrials.gov. We also handle any amendments, ensuring your trial registration always matches your trial protocol and stays compliant with rules and regulations.