At Humble Aim Enterprises, we provide independent readiness consultancy for hospitals evaluating a clinical-trials department. The scope may include feasibility, governance, infrastructure, records and staff preparation; study, sponsor, ethics and regulatory decisions remain with the responsible organisations.
Our Services:
1. Formation and Registration of Institutional Ethics Committee
Humble Aim Enterprises provides the assistance in formation of Institutional Ethics Committee of the Hospital and formualtion of Standard of Procedures (SOP for the functioning of Ethics Committee).
2. Regulatory and Ethics-readiness Assistance:
Supporting the organisation of applicable information for CDSCO, ethics-committee and DHR processes. The hospital and investigators remain responsible for accurate submissions, compliance and authority decisions.
3. Department Setup and Infrastructure Development:
Assisting with department workflow, infrastructure, records and technology planning according to the hospital's proposed research scope and approved responsibilities.
4. Staff Training and Development:
Providing role-based preparation covering Good Clinical Practice, clinical-trial management, regulatory responsibilities, participant handling and ethical practices. Training or certification completion is not guaranteed.
5. Phase 1-4 Clinical Trial Initiation and Management:
Supporting hospitals with study-readiness coordination, document systems and role clarity. Each study remains subject to sponsor selection, ethics review, applicable regulatory requirements and registration on the Clinical Trials Registry - India where required.
6. Pharmaceutical Company Engagement:
Helping hospitals present verified service, investigator and infrastructure information during research-feasibility discussions. No sponsor selection or project award is promised.
7. Empanelment with SMO and Sponsors:
Assisting hospitals in organising due-diligence information requested by sponsors or Site Management Organisations. Any engagement remains subject to the parties' own review and approval.
8. Research Feasibility and Governance:
Reviewing whether proposed research activity fits the hospital's services, investigators, participant safeguards, ethics oversight, infrastructure and financial controls before commitments are made.
Why Choose Humble Aim Enterprises?
- - Defined Scope: Responsibilities and limitations are agreed before implementation support begins.
- - Customized Solutions: Tailored solutions to fit unique hospital needs and goals.
- - Governance Focus: Participant protection, ethics, records and accountable oversight remain central to readiness work.
- - Practical Follow-up: Reviews and action tracking are planned according to the agreed engagement.
Humble Aim Enterprises can help a hospital structure an initial clinical-research readiness review. Research, regulatory, ethics, sponsor and financial decisions remain with the responsible organisations.
Typical Readiness Work
- Mapping applicable regulatory, ethics and registration responsibilities.
- Reviewing department infrastructure, records and role ownership.
- Planning role-based staff preparation within the agreed scope.
Why Clinical Trials?
Clinical trials require a suitable investigator team, participant protections, ethics and regulatory compliance, dependable records and study-specific feasibility. Commercial or clinical outcomes should not be assumed.