SM Research
End-to-End Phase I-IV Clinical Development
ICH‑GCP & ISO 14155
21 CFR Part 11
500+ global sites
FDA/MHRA‑ready
Our Impact
500+
Global Sites
9+
Therapeutic Areas
Phase IIV
Clinical Development
Therapeutic Areas
Ophthalmology, Respiratory, Neurology, Endocrinology, Oncology, Dermatology, Infectious Diseases, Pain, Rare Disease
End-to-end Services
Protocol design, site selection, project management, monitoring, data management, biostatistics, medical writing
Recent Studies
Phase I FIH, Phase II PoC, Phase III pivotal, Phase IV observational
Quality & Compliance
ICH-GCP, 21 CFR Part 11, GDPR, ISO 14155
Clinical Development
We deliver full-service clinical trial support across Phases I-IV: feasibility & start-up, site activation, monitoring, data management, biostatistics, medical writing and regulatory submissions. Our experienced teams and global site network help sponsors accelerate development while ensuring patient safety and data integrity.
Core Capabilities
Project Management & Monitoring: riskbased oversight, KPI tracking, vendor coordination
Data Management & Biostatistics: EDC build and validation, data cleaning, statistical analysis and reporting
Regulatory Submissions
Safety & Pharmacovigilance: case processing, medical review, aggregate reports
Case Studies & Expertise
Oncology Operations
Feasibility, start-up, monitoring and enrollment delivery.
Biometrics Excellence
EDC build, data management, programming and analysis outputs.
Regulatory & QA
Inspection readiness, submissions and GCP quality systems.
Our mission
Our mission is to advance healthcare by delivering high-quality, efficient clinical trials that bring safe and effective therapies to patients faster. We combine scientific rigor, operational excellence, and patient-centered design to exceed sponsor and regulatory expectations.
Capabilities
Clinical operations, safety, biometrics, medical writing, and regulatory strategy to support your program end‑to‑end.
Therapeutic Areas
Oncology
Solid tumors, hematology, immuno-oncology, biomarker-driven designs
Neurology
Epilepsy, movement disorders, neurodegeneration, rare CNS disorders
Respiratory
Asthma, COPD, interstitial lung disease, pulmonary infections
Ophthalmology
Retina, glaucoma, anterior segment, inflammatory eye disease
Endocrinology
Diabetes, obesity, thyroid and metabolic disorders
Dermatology
Psoriasis, atopic dermatitis, acne, autoimmune skin disease
Infectious Diseases
Antivirals, antibacterials, vaccines, emerging pathogens
Pain
Acute and chronic pain, neuropathic and musculoskeletal conditions
Rare Disease
Genetic and orphan indications, natural history and interventional trials