Deep Dive to Deliver Quality

A Clinical Research Organisation (CRO) committed to ethical research, regulatory excellence, and public health impact.

Years Of Experience
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About Shodh Clinicals

Shodh Clinical Solutions is a Clinical Research Organisation (CRO) established in March 2020 as a Limited Liability Partnership (LLP). The organization operates with a strong commitment to public health, ethical research, and regulatory-compliant clinical research practices at both national and global levels.

 

Shodh Clinical Solutions works closely with academic researchers, investigators, SMEs, research institutes, pharmaceutical companies, and policy-focused organizations to support high-quality research initiatives, particularly in the public goods and unmet-needs space.

 

At the core of its philosophy is a distinctive 3D approach:

“Deep Dive to Deliver Quality”
- ensuring scientific rigor, operational excellence, and credibility across all research programs and initiatives.

CALL FOR CONSULTATION

+91-9818884738

Vision & Mandate

To cater to public health needs by delivering cost-effective, high-quality clinical research services that adhere to national and international standards.

Mandate

Shodh Clinical Solutions is mandated to:

  • Support and facilitate research programs in compliance with applicable regulations and guidelines
  • Enable efficient study start-up, planning, and high-quality implementation
  • Enhance clinical research capabilities across institutions and professionals
  • Empower and motivate the scientific and medical fraternity
  • Create awareness through structured training programs and workshops
  • Promote ethical, transparent, and credible research practices aligned with global best standards

Organizational Approach

Shodh Clinical Solutions adopts a collaborative and integrated research model, providing:

OUR SERVICES

Solutions & Services Offered

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Strategic & Advisory Services

- Strategic Scientific Advisory
- Regulatory Advisory and Compliance Support
- Grant and Proposal Writing

Clinical & Operational Services

- Clinical Operations and Site Management
- Project Planning and Project Management
- Study Start-up and Site Selection
- Quality Management Systems (QMS)
- SOP and Operational Manual Development

Clinical Data Management

- CRF development (paper and EDC)
- Data Management Planning
- Data entry, discrepancy management, and medical coding
- SAE reconciliation and external data handling
- Interim and final data listings
- Database lock and closure support

Medical & Safety Services

- Medical Monitoring and Oversight
- Safety Reporting and Pharmacovigilance
- Clinical Study Reports
- Manuscripts and Publications
- Investigator Brochures, Protocols, ICDs

GxP, Audit & Quality

- GCP, GCLP, GLP compliance support
- GxP Audits
- Quality Assurance and Risk Management

Training & Capacity Building

- Bioethics in Clinical Research
- GCP (Basic, Refresher, Advanced – ICH E6 R3)
- GCLP / GLP
- Clinical Research Methodology
- Safety Reporting (including SUGAM Portal)
- Biostatistics
- Medical Writing
- CRC / CRA Induction Programs
- Clinical Trial & Project Management
- Workshops
- Customized research training programs

Resourcing for Research

- Internship programs with hands-on training
- Mentoring and deployment of research professionals
- Resourcing for Sponsors, CROs, Clinical Sites, and Research Units
- Setting up Clinical Research Units (CRUs)
- Site Management Organization (SMO) services

Team & Leadership

Shodh Clinical Solutions is led by a multidisciplinary team of medical, scientific, regulatory, and operational professionals with:

  • Strong academic foundations
  • Experience across diverse therapeutic areas
  • Extensive exposure to clinical development programs
  • Proven expertise in grant writing, protocol design, medical monitoring, data management, and regulatory research
  • Active involvement in national-interest research initiatives

Dr. Monika Bahl

Founder & Managing Director

MBBS, MBA | Over 25 years of experience in clinical research, project management, training, and organizational leadership.

Er. Vinod Kalra

Director, Administrative Services

Professional Engineer with 40+ years of experience in defense services, administration, finance, and business development.

Expert Consultants & Advisors

The organization is supported by senior experts in:

  • Clinical Research & Drug Development
  • Regulatory Affairs
  • Quality Assurance (GCP, GCLP, GLP)
  • Medical Writing and Safety
  • Academic and Ethics Committee advisory roles

Stakeholders & Collaborators

Shodh Clinical Solutions actively strengthens industry-academia partnerships and collaborates with:

  • Medical Colleges and Academic Institutes
  • Clinical Sites and Hospitals
  • Pharmaceutical Companies
  • CROs and Research Organizations
  • Government and Public Health Institutions

Collaborations include associations with AIIMS, ICMR institutes, major medical colleges, universities, biotech and pharma companies, diagnostic centers, and global research initiatives, enabling wide research reach and impact.

Training Footprint & Impact

Shodh Clinical Solutions has conducted numerous national-level and institutional training programs, both online and onsite, for:

  • Investigators
  • Ethics Committee members
  • Postgraduate students
  • Clinical research professionals
  • Faculty and clinicians

The organization’s training programs are widely recognized for:

  • Regulatory accuracy
  • Practical applicability
  • Interactive learning formats
  • High participant satisfaction and repeat engagement

Testimonials from AIIMS faculty, ICMR scientists, ethics committee members, professors, and clinicians consistently highlight clarity, depth, relevance, and impact.