Assess the current state of clinical trial management against a structured set of criteria rather than impressions.
Managing Clinical Trials for New Medicines
Practical training in clinical trial management, grounded in real cases and applied to your own operation.
📍 Cairo🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points
Course Overview
Accreditation bodies assess clinical trial management on documented evidence of consistent practice. The data supporting this aspect of health and pharmaceutical services is usually present but rarely assembled into a decision. Every module pairs a short input on the wider health and pharmaceutical services agenda with structured practice on the participant's own material. Practitioner evidence points the same way: clinical trial management improves fastest where responsibility for it is named and owned. The course covers the practice within health and pharmaceutical services at the level of detail needed to act, and stops there. It is designed for mixed groups, so that this part of health and pharmaceutical services is examined from more than one functional angle. Improvement in clinical trial management stalls when it depends on one capable individual rather than a defined method. The programme builds the judgement to know which parts of this aspect of health and pharmaceutical services to standardise and which to leave flexible. The closing exercise tests whether the participant's plan for the health and pharmaceutical services capability survives a hostile question.
Expected Learning Outcomes
Control cost per episode within clinical trial management without shifting risk to patients.
Plan continuity of clinical trial management during surge, outbreak and emergency.
Build the internal capability for clinical trial management rather than depending on external support indefinitely.
Assess and control infection risk associated with clinical trial management.
Verify that improvements to clinical trial management have held six months after they were introduced.
Manage the supply chain and cold chain supporting clinical trial management.
Who Should Attend
Infection prevention and control practitioners covering clinical trial management.
Newly appointed managers taking on clinical trial management for the first time.
Quality and patient safety officers monitoring clinical trial management.
Clinical department heads responsible for clinical trial management.
Medical directors overseeing clinical governance of clinical trial management.
Procurement and contracting staff whose agreements set obligations around clinical trial management.
Course Modules
Clinical trial management: quality indicators and patient outcome
2 sessions · 8 pointsSession 1Infection risk created by clinical trial management
- Test the procedure for clinical trial management against a realistic scenario.
- Distinguish symptoms from causes when clinical trial management underperforms.
- Map the handovers in clinical trial management between functions and secure them.
- Plan the sequence in which improvements to clinical trial management will be introduced.
Session 2Comparing clinical trial management with recognised practice
- Collect evidence on the present handling of clinical trial management before proposing changes.
- Check that consent processes within clinical trial management are genuinely informed.
- Identify where judgement in clinical trial management is legitimate and where it is not.
- Confirm patient data handled within clinical trial management meets confidentiality obligations.
Clinical trial management: supply, cold chain and availability
2 sessions · 8 pointsSession 1Auditing clinical trial management at the bedside, not in the binder
- Arrange the handover of clinical trial management so capability survives staff changes.
- Define escalation criteria for deterioration detected through clinical trial management.
- Assemble the accreditation evidence pack for clinical trial management.
- Confirm that reporting on clinical trial management reaches the people who can act.
Session 2What patients actually experience during clinical trial management
- Confirm licensing and regulatory requirements applying to clinical trial management are met.
- Prepare the summary of clinical trial management that senior management will read.
- Confirm competence and continuing development for staff delivering clinical trial management.
- Confirm that contractual obligations around clinical trial management are understood.
Clinical trial management: staffing, capacity and demand
2 sessions · 8 pointsSession 1Matching staffing on clinical trial management to real demand
- Map the clinical workflow for clinical trial management as it is actually performed.
- Decide what will be stopped to create capacity for clinical trial management.
- Verify six months later that changes to clinical trial management have held.
- Reduce the variation in how clinical trial management is carried out between teams.
Session 2The evidence assessors will ask for on clinical trial management
- Establish who is informed, consulted and accountable in clinical trial management.
- Confirm the incident reporting route for clinical trial management is quick and non-punitive.
- Apply structured root cause analysis to the last adverse event involving clinical trial management.
- Audit clinical trial management by observing practice, not by reading policy.
Clinical trial management: medication and treatment safety
2 sessions · 8 pointsSession 1Building lasting competence in clinical trial management
- Identify infection transmission risks created by clinical trial management and control them.
- Check that records of clinical trial management answer the questions likely to be asked.
- Match staffing levels on clinical trial management to measured demand across the week.
- Close the loop: confirm changes to clinical trial management improved the indicator they targeted.
Session 2The cost of clinical trial management and how to present it
- Select quality indicators for clinical trial management that measure outcome rather than activity.
- Reduce unwarranted variation in clinical trial management between shifts and sites.
- Measure patient experience of clinical trial management and feed it back to the team.
- Anticipate the objections clinical trial management will raise and prepare the answers.
Choose the package that suits you
Silver Package
At least 3 people
USD1,250
- Workshop or Program Participation
- Airport Transfers
- Customized Badge
- Expert Mentorship (Private Sessions)
- Supervision & Secretarial Services
- Accredited Certificate of Participation
- Complete Training Kit
- Coffee Break
- Closing Ceremony
Gold Package
At least 3 people
USD1,850
- 5-night stay in a 5-star hotel
- Workshop or Program Participation
- Airport Transfers
- Customized Badge
- Expert Mentorship (Private Sessions)
- Supervision & Secretarial Services
- Accredited Certificate of Participation
- Complete Training Kit
- Coffee Break
- Closing Ceremony
Complete your registration
We will contact you within one business day to confirm.