A clinical trial of a medicinal product generally needs approval from the Directorate General of Drug Administration and ethical clearance through the Bangladesh Medical Research Council's national ethics committee or an appropriate institutional review board. Importing investigational products and exporting biological samples can require separate permissions. Requirements depend on the type of study, product and sponsor, and practice can change, so we confirm the current position for each study. Our contracts then allocate responsibility for each application and make start of recruitment conditional on approvals being granted and remaining valid. We also build in renewal and amendment steps.

No. A CRO agreement governs the relationship between the sponsor and the CRO, including which trial obligations are delegated. Sites still need their own agreements, either directly with the sponsor or with the CRO acting on the sponsor's behalf, covering budgets, investigator duties, data access, confidentiality, publication and indemnity. The two layers must be consistent. Many disputes arise where the CRO agreement promises the sponsor something the site agreement does not deliver, such as data access rights or a particular publication restriction, so we review both together before signature.

Usually it can be used as a starting point, but rarely without changes. Global templates may assume regulatory steps, insurance arrangements, payment mechanics or data transfer routes that do not match Bangladesh practice. Local hospitals and ethics committees may also expect particular clauses on injury compensation, governing law or publication. We prepare a Bangladesh addendum or adapted template that keeps the sponsor's core protections while addressing local requirements, which often shortens negotiation time with institutions and avoids repeated questions from ethics committees during review. We also keep a record of agreed positions for later sites.

In industry-sponsored trials, the sponsor usually owns the trial data and any inventions relating to the investigational product, while the institution keeps its medical records and may receive a licence to use data for research, teaching and patient care. Investigator-initiated studies often follow a different model. Ownership terms should be consistent across the CRO, site and vendor agreements and compatible with the Patent Act 2023 and employment arrangements of investigators. We draft clear ownership, licence and invention disclosure clauses so that rights can be relied on in later patent filings or licensing.

Participant protection must come first. The sponsor typically commits to cover reasonable medical costs and compensation for injury caused by the investigational product or protocol procedures, supported by insurance that meets ethics committee and regulatory expectations. Site agreements then allocate responsibility where injury results from site negligence or failure to follow the protocol. Informed consent documents, insurance certificates and contracts should all say the same thing. We draft compensation and indemnity provisions so participants are protected and the commercial parties understand where each risk ultimately rests. Clear wording reduces later claims and complaints.

It may be possible, but participant data is sensitive personal data and the Personal Data Protection Act 2026 imposes conditions on processing and cross-border transfer. The consent form, the protocol and the contracts must explain what data is shared, in what form, with whom and for what purpose. Pseudonymisation is common but does not remove all obligations. We advise on lawful bases, transfer safeguards, security commitments and data processing agreements with CROs, laboratories and technology vendors, so cross-border data flows in a clinical trial are documented and defensible. Each transfer should be recorded in the clinical trial documentation.

Payments should reflect fair market value for work actually performed, be documented in the site agreement and budget, and be paid through transparent channels, often to the institution rather than individuals. Anti-corruption laws in Bangladesh and, for many sponsors, foreign laws such as the UK Bribery Act or US FCPA apply. Payment schedules should be linked to milestones and reconciled against monitoring reports. We draft payment terms, invoicing requirements and anti-bribery clauses, and review proposed budgets for features that might raise compliance concerns during audits or investigations. We review honoraria and travel support similarly.

The agreements should allow suspension or termination for safety reasons, regulatory instruction, loss of approval, poor recruitment or the sponsor's business decision. They must also deal with continuing care of enrolled participants, return or destruction of investigational products, final payments for work done, record retention and close-out visits. We draft these provisions so obligations to participants survive termination and so the commercial consequences are predictable. If a dispute follows, our dispute resolution team can advise on negotiation, mediation or arbitration. Clear close-out terms also protect continuing participant care after a clinical trial ends early.