The sponsor of a study will assign one or multiple principle investigators (PI), usually a doctor. Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Traditionally, clinical trials have never been designed with patient-centricity in mind. Although the patient has always been part of a trial as a human subject, they were never really considered an important stakeholder. Communication and engagement are ..read more

Are you temporarily understaffed in your clinical trials and in need for support? Contact us and we’ll come up with a solution that fits your needs! At Delta Healthcare Consulting we provide all kinds of staff solutions like: study nurses, laboratory technicians, project managers, data entry staff, clinical trial home nurses, … Contact us for the right solution! Het bericht Temporarily understaffed in your clinical trials? verscheen eerst op Deltaclinical ..read more

We’re happy to anounce that Delta Healthcare Consulting is now a member of BeCRO, the Belgian Association of Clinical Research Organisations. Het bericht BeCRO member verscheen eerst op Deltaclinical ..read more

As from today, we start with the Clinical Trial Rescue-project. Some patients which are participating in clinical trials are not able to join the hospital as a result of the Corona crisis. Fore these patients we can provide home visits, executed by a trained clinical trial nurse who is able to take blood samples, vital signs, AE assessment, administration of IMP, … We established a task-force for a fast start-up of the home visits Do you have a problem with your clinical trial? Contact us: geert.briers@deltaclinical.be Het bericht Covid-19 – Clinical Trial Rescue verscheen eerst op Delta ..read more

Yesterday we attended the symposium ‘Drug Development from Bench to Bedside’, organised by the University Hospital of Ghent. It was an interesting day on a great location with inspiring lectures. We’re looking forward to part 2 today. Find out more about the symposium. Het bericht Drug development from bench to bedside verscheen eerst op Deltaclinical ..read more

For many people the summer holidays are the ideal moment to dust off the suitcases and enjoy relaxing or exploring abroad.  But is this possible while participating in a clinical trial? Often, medication has to be administered on a regular basis or certain parameters need to be measured, making it difficult to plan a trip. Adios sea, beach and palm trees? Wait… don’t throw away your slippers just yet. Because even at camp or on holiday the follow-up for your clinical trial can be assured. The time when going on a trip during your participation in a clinical trial was an absolute no-go, has ..read more

Although home visits are associated with a lot of important benefits, some challenges should also be noted. Sponsors often link home visits to a higher risk.  Although this is not necessarily the case, certain precautions should be considered. For example data security needs to be a priority.  As many sensitive patient data is transmitted over the internet, additional efforts should be made to limit the possibility of a data breach. It should however be noted that as the younger generations are very liberal in sharing personal information online, the sense of privacy might differ in the future ..read more

Investigator site An important task of the investigator site is the recruitment of patients. Unfortunately, 2 out of 3 sites fail to meet the patient enrolment requirements. Adding a high drop-out rate, due to variable reasons, such as schedule conflicts, inconvenient location, forgetting visits, family matters, etc., results in a low percentage of 25% of all screened patients who actually make it to the end of the trial. According to a research conducted by the Centre for Information & Study on Clinical Research Participation (CISCRP), the 5 most common reasons for patients to leave a tri ..read more

As the organization of home visits can be quite complex, some clinical research organizations (CRO) have specialized in offering services specifically tailored to home visits during clinical trials. These services can include: The transportation, preparation and administration of the investigational product Training and education of the caregiver and/or patient Observation Parameters, taking blood samples, ECG’s, … Obtaining Informed Consent The collection, preparation, packaging and shipping of samples Reporting adverse events (AE) Reporting patient outcome measures and carrying out a questio ..read more

Some time ago, the idea of bringing a clinical trial to the patient’s home was unthinkable, but recently more and more research companies are convinced of the benefits. The overall goal of a clinical trial is to develop new and better treatments for the patient. Therefore, each development that contributes to achieving this goal faster, should be considered. As more and more pharmaceutical companies are getting familiar with patient-centricity, home visits, as opposed to on-site visits, are gaining a lot of interest. It would be impossible to relocate a whole trial to a patient’s home. A more ..read more