Enabling Efficient, Ethical & High-Quality Clinical Research Execution

Swastik Clinical Research is a trusted Site Management Organization (SMO) in India, partnering with sponsors, CROs, and investigators to deliver end-to-end clinical trial site management solutions.

50+

Clinical Trial Sites Supported

10+

Therapy Areas

15+

Cities Across India

GCP

Compliant Operations

About Us

Swastik Clinical Research is a specialized Site Management Organization (SMO) committed to strengthening the clinical research ecosystem in India. We provide operational and regulatory support to sponsors, CROs, and investigators, ensuring trials run better, faster, and in compliance with global standards.

Our mission is to deliver reliable, patient-centered site management support while upholding the highest ethical standards. Our vision is to be India’s most trusted clinical research execution partner.

Our Services

Site Activation

Accelerate initiation with regulatory-ready documentation.

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Site Activation

Key Offerings

  • IEC/IRB submission coordination
  • Regulatory authority submission support
  • Site staff training (GCP/protocol-specific)

Our startup teams compress time from site selection to First Patient In (FPI), saving sponsors both time and cost.

Study Coordination

Day-to-day operational support for smooth trial execution.

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Study Coordination

Key Offerings

  • Patient visit scheduling and coordination
  • Protocol deviation tracking and management
  • Monitoring visit facilitation

We ensure protocol adherence and efficient patient flow, while keeping sponsors updated with regular performance reports.

Regulatory Compliance

Ensuring documentation integrity and perpetual audit readiness.

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Regulatory Compliance

Key Offerings

  • Investigator Site File (ISF) setup and review
  • Essential document tracking and gap analysis
  • Audit and inspection readiness preparation

Our team maintains compliance with ICH-GCP and Indian regulations, keeping sites inspection-ready at all times.

Patient Recruitment

Targeted strategies to meet enrollment milestones.

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Patient Recruitment

Key Offerings

  • Community outreach and engagement
  • Screening coordination and patient flow management
  • Retention strategies to minimize dropout

Our recruitment strategies combine site-level outreach and screening coordination to help sites meet enrollment goals on schedule.

Quality Management

GCP-aligned oversight and audit readiness.

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Quality Management

Key Offerings

  • Internal quality checks and documentation review
  • Pre-audit/pre-inspection readiness support
  • Corrective and Preventive Action (CAPA) support

Quality is the foundation of every service we provide, ensuring sites operate to the highest standards throughout the study lifecycle.

Quality & Compliance

Swastik Clinical Research follows structured, SOP-driven workflows to ensure ethical conduct and data integrity.

ICH-GCP & CDSCO Aligned

Our document systems are inspection-ready from Day 1.

ALCOA+ Principles

Maintaining accurate, legible, and contemporaneous records.

Safety First

SAE reporting within 24 hours to Sponsors and Ethics Committees.

Therapeutic Areas

Oncology

Solid tumors, hematology, and immuno-oncology.

Oncology

  • Safety reporting
  • Immuno-oncology support
  • Complex eligibility management

Cardiology

Heart failure, hypertension, and interventional cardiology.

Cardiology

  • Patient recruitment
  • ECG data handling
  • Compliance oversight

Endocrinology

Diabetes, obesity, and metabolic disorder trials.

Endocrinology

  • Early-phase metabolic studies
  • Large outcomes trials
  • Recruitment strategies

Vaccines

Preventive and therapeutic studies with cold chain logistics.

Vaccines

  • Cold chain management
  • High-volume enrollment
  • Multi-site coordination

Infectious Disease

Acute and chronic anti-infective study management.

Infectious Disease

Providing rapid enrollment and high-quality data for critical studies.

Dermatology

Atopic dermatitis, psoriasis, and alopecia trials.

Dermatology

  • Photography protocol support
  • Patient flow management
  • Investigator assessments

* Additional therapeutic areas available on request.

Contact Us

Ready to accelerate your next clinical trial in India? Get in touch with our team today.