MEDICAL, HEALTH AND LIFE SCIENCES

Under this practice sector, we advise academic research institutions, Non- Governmental
Organisations, Inter-Governmental Organisations, Pharmaceutical Companies, Sponsors and Contract Research Organisations on bio-medical, behavioural and data collection studies involving human subjects, with specific reference to:

• The National and International Regulatory requirements for the conduct of Clinical Trials under FDA, CFR, WHO, EU, NDPA, Belmont and Helsinki Codes;
• The application of Good Clinical Practice guidelines;
• Ethical/legal review of the protocol and authorisation by the National Authorities;
• The appointment and responsibilities of Ethical/ Institutional Review Boards;
• Protection of the rights and welfare of research participants;
• Collaborative agreements with National Research Institutions;
• Clinical trial and Site Agreements;
• Material Transfer Agreements and licensing of compounds, processes, and technology platforms;
• Drafting of Informed Consent Agreements, review of applicability to social, cultural and personal circumstances of participants and continuous monitoring for compliance;
• Data and Patient Confidentiality;
• Benefit sharing;
• Dispute Resolution arising out of the Conduct of the trial