Decentralised Clinical Trials
- Decentralisation (between Site and Participant), and
- Centralisation (between Sponsor/CRO and Site).
1.Decentralised Clinical Trials through MERCLINCO’s Innovative Research Methodology.
“With the evolution of decentralized trials, patient access could be expanded where ‘bricks and mortar’ infrastructure may be limited and in the African environment access can be improved. Patient motivation and engagement in trials, both recruitment and retention related, is high given those with unmet medical needs” – IQVIA Africa Health Summit.
- Business continuity strategy – mitigate disruptions like COVID 19 pandemic.
- Accelerate clinical trial delivery – health & financial benefits.
- Exposure to trial-naïve participants.
- Increase recruitment options.
- Retention benefits.
How – Leverage existing resources
- Public are changing preferences of accessing healthcare – this is another option to the patient.
- High volume of patients – faster recruitment.
- e-Consent can be conducted at a computer-terminal set-up for this purpose at the local pharmacy.
- Easily accessible & acceptable to participants.
- Convenient locations.
- Open after hours and weekends – critical for people working 9-5 jobs.
- Delivery vehicles to deliver to patient/participants home.
- Provide participant training on use of medical devices & medication.
- Motivate compliance & retention because of the trust relationship built between the pharmacist/staff & client.
- Highly effective – proven during the COVID 19 pandemic.
- Acceptable as a delivery model of healthcare – benefits realised during the COVID 19 pandemic.
- Decrease in exposure to airborne and other diseases when attending clinical trials centres – some of which are based in hospitals or busy GP practices.
- Comfort of your own home – decreased need for nursing care.
- Decreasing the ever-increasing demand of the ever-decreasing resources in healthcare.
- No need to arrange for transport – mitigation of another major challenge especially for the elderly even more so in developing countries & rural areas.
- No need to arrange care-givers to take the participant to the CT centre.
- Family + Community care & support.
- Psychological benefits result in greater acceptability better healthcare outcomes.
Community Liaison Officer in CABs & YABs
- Adequate and appropriate use of technology.
- Digitising the processes.
- Future advancements e.g. Oracle ‘s Larry Ellison latest pursuit to create a “National public health electronic record database” – both national and global databases.
- 24 hour helplines set up at the Clinical Trail Site for:
- Information or guidance for participants on a study.
- Medical assistance or emergencies.
2.Centralised Clinical Trials through MERCLINCO’s CHS, “Centralised Hub Service” (between Sponsor/CRO & Sites).
- It is a central point of contact for all issues at any one of our global sites – you may address your problem/query directly with our CHS and they will resolve it.
- Turnaround times for response are max of 48 hours.
- We will navigate, in the different countries, on your behalf, the minefield of different:
- Regulatory requirements.
- Registration requirements for staff.
- Cultural belief systems – very important for study feasibilities, recruitment practices and retention methodologies.
- Logistics support – MERCLINCO SMO has these networks in place in the countries we operate.
- Relationships with the entire ecosystem of clinical trials in each of the countries we operate – established over many years of working together and building trust through delivering on our commitments with integrity, quality and on time – mostly ahead of schedule.
- Stability assurance at site level – staff training and continuity of trials as per contractual commitments.