REGULATORY & ETHICS SUBMISSIONS
TASK specialist services includes an in-house Regulatory team handling all aspects of regulatory affairs as well as consulting services. Regulatory responsibilities continues throughout the life cycle of a product from research and development stage to post-marketing. This includes to secure regulatory approvals (i.e., SAHPRA) and ethics favorable opinion in compliance with local and international standards and industry guidelines of clinical research development.
TASK Regulatory services & packages
All aspects of Regulatory(i.e., SAHPRA) and ethics submissions such as document preparations to actual compiling and submission of new studies.
Protocol amendment submissions and processes and ongoing trial notifications and correspondence to maintain participant safety and compliancy.
Informed consent drafts and reviews.
Clinical trial registration (SANCTR/PACTR/CLINICALTRIALS.GOV)
Investigator site file set up and maintenance training and services.
Sponsor trial master file set up, maintenance training.
Regulatory workshops for new sites or regulatory staff.
