i. To play a lead role in initiating, planning, executing, monitoring and controlling,
analysis and reporting a project
ii. To communicate and present trial effectively whenever needed
iii. To organise and motivate others
iv. To manage the trial budget.
Effective trial management includes the following:
i. Proper planning of the project
iii. Timely approval of the trial
iv. Proper designing of the clinical trial protocol
v. Good collaboration between the trial staff and participants
vi. Good communication between each section of the trial pyramid
vii. Proper management of the budget
viii. Proper training to the staff
ix. Appropriate credit will be given to the responsible persons
x. Effective recruitment of staff and trial participants
xi. Efficient evidence and study in the support of the trial
xii. Genuine reporting to the competent authority
xiii. Compliance with the regulatory guidelines for clinical trials
xiv. Efficient management of the resources
Effective management of clinical studies will only be possible if all the stakeholders
come together and ‘own’ the project.
1. Explain the general considerations of INDA.
2. Explain the procedure for NDA filing in detail.
1. What are bioequivalence studies? Describe in detail.
2. Explain the importance of biostatistics in drug development process.
3. What are the contents of IB?
4. What are the general considerations for data submission in FDA?
b. Management of clinical studies
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