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Clinical Trials & Site Management (SMO)

Well-run sites deliver clean data on time.

Why It Matters

We support investigators and hospitals with feasibility, recruitment, informed-consent workflows and GCP-ready site operations, so studies run smoothly and stay inspection-ready.

Who It Is for

Investigators, hospitals, research sites, SMOs and CROs.

See the service Brochure

What We Cover

Feasibility assessments, site selection dossiers and investigator meetings
Participant recruitment and retention plans, and informed-consent workflows
Source data verification support
Audit-ready TMF/ISF oversight and GCP compliance monitoring

Benefits

Better Recruitment

Realistic feasibility and retention plans.

Clean Source Data

Coordinators trained in ALCOA+ documentation.

Smooth Monitoring

Organised ISFs and fast query turnaround.

GCP Confidence

Ongoing compliance checks at the site.

Related Courses

High demand

Clinical research & operations

Clinical Research Associate & Coordinator (CRA/CRC)

Run and monitor a study site: feasibility, consent, visits, source documents, SDV and site files.

6 weekends
Live online with recordings · Next batch: on request
Pharmacy, life sciences, nursing and medical graduates

What you will learn

ICH-GCP E6(R3), NDCT Rules 2019 & ICMR ethics
Feasibility, SQV, SIV and close-out visits
Informed consent process & documentation
Source data verification & monitoring reports
ISF/eTMF, IP accountability and SAE reporting

Most complete

Clinical research & operations

Professional Diploma in Clinical Research, Data Management & Drug Safety

Clinical operations, CDM and pharmacovigilance with biostatistics basics, a capstone project and career preparation.

4 months · weekends
Live online with recordings · Next batch: on request
Graduates who want an in-depth, job-focused programme

What you will learn

Clinical operations and GCP
Clinical data management
Pharmacovigilance
Biostatistics basics
Capstone project
Resume, LinkedIn and mock interviews

Have a Question about This Area?

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