Clinical Trials & Allied Services

Specialized Research Services

Investigator Initiated Studies (IIS)

We empower academic and clinical investigators to turn their research ideas into regulated clinical trials. Our dedicated IIS team supports:

Protocol development and statistical design validation
Ethics Committee (EC) submission & approval management
End-to-end Data management and biostatistics
Medical writing for high-impact publication

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Neurological Disorders

Expertise in neurodegenerative diseases, epilepsy, and cognitive disorders.

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Cardiovascular Diseases

Experience in hypertension, heart failure, and stroke prevention trials.

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Rare Diseases

Specialized recruitment and retention strategies for rare patient populations.

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Oncology

Complex Phase I-III oncology trials with biological endpoint tracking.

Real World Evidence (RWE)

Bridging the gap between clinical trials and clinical practice. We design rigorous observational studies to generate evidence on:

Long-term drug safety, efficacy, and utilization patterns
Health economics and outcomes research (HEOR)
Patient-reported outcomes (PROs) and Quality of Life
Comparative effectiveness studies in diverse populations

Decentralized & Hybrid Trials (DCT)

Leveraging technology to bring trials to the patient, reducing site visits and increasing diversity in recruitment.

Tele-health & Remote Monitoring
eConsent & Virtual Recruitment

Home Nursing & Local Lab Integration
Wearable Data Integration (IoMT)

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Multi-Site Trials

Coordinate and manage clinical trials across multiple hospitals and research centers in India

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Data Management

Professional data collection, cleaning, and statistical analysis services

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Quality Assurance

GCP-compliant monitoring, auditing, and quality control processes

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Regulatory Submissions

Expert support for ethics committee and CDSCO regulatory approvals

Study Feasibility & Protocol Support

Comprehensive planning services to set your clinical trial up for success

📍 Site Identification

• Hospital and clinic network assessment
• Investigator qualification review
• Patient population analysis
• Site capability evaluation

📝 Protocol Development

• Scientific and medical writing
• Endpoint selection and validation
• Statistical analysis planning
• CRF design and development

💰 Budget & Timeline

• Cost estimation and budgeting
• Resource allocation planning
• Realistic timeline development
• Risk assessment and mitigation

👥 Patient Recruitment

• Recruitment strategy development
• Patient screening optimization
• Retention planning
• Community outreach support

Ethics Committee & Regulatory Submissions

Navigate regulatory approvals with confidence

🏛️ Ethics Committee Support

Complete preparation and submission of ethics committee applications, informed consent forms, and supporting documents

🇮🇳 CDSCO Submissions

Regulatory filings with Central Drugs Standard Control Organisation for clinical trial permissions

📄 Documentation Management

Maintaining regulatory binders, essential documents, and audit-ready documentation

🔄 Amendment Support

Protocol amendments, safety reporting, and ongoing regulatory correspondence

Site Management & Monitoring

Professional site coordination and GCP-compliant monitoring services

Site Initiation

Site activation, investigator meetings, staff training, and trial material distribution.

Investigator Meeting (IM) coordination
Product Training & GCP Certification
Investigational Product (IP) Logistics

Clinical Monitoring

Regular on-site and remote monitoring visits to ensure protocol compliance and data quality.

RBM Standards ↗

Source Data Verification

Comprehensive SDV to verify accuracy and completeness of case report forms vs source documents.

100% Critical Data Verification
ALCOA-C Data Quality Standards
eSource (DDC) Integration

CliniFlow SDV Module

Data Management & Biostatistics

Data Management Services

✓ Database design and validation
✓ eCRF and EDC setup (CliniFlow platform)
✓ Data entry and double data entry
✓ Data cleaning and query management
✓ Database lock and data export
✓ CDISC SDTM compliance (when required)

Biostatistics Services

✓ Statistical analysis planning (SAP)
✓ Sample size calculation
✓ Randomization and blinding
✓ Interim and final analysis
✓ Statistical reports and tables
✓ Meta-analysis support

Safety Management (AE/SAE Workflows)

Comprehensive pharmacovigilance and safety reporting

⚠️ Adverse Event Collection

Systematic capture, coding, and documentation of all adverse events during trials

🚨 SAE Reporting

Expedited serious adverse event reporting to regulators, ethics committees, and sponsors

📊 Safety Database

Centralized safety database and ongoing safety surveillance throughout the trial

📈 DSMB Support

Data Safety Monitoring Board coordination and safety report preparation

The Clinical Trial Pathway

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Phase I

Safety & Dosage

Small group (20-100)

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Phase II

Efficacy & Side Effects

Medium group (100-300)

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Phase III

Efficacy vs Standard

Large group (1000-3000)

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Review

Regulatory Approval

CDSCO / FDA Submission

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Phase IV

Post-Market Safety

Surveillance & Monitoring

Quality & Compliance

VedaRx operates under rigorous quality standards aligned with international guidelines

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ISO Compliant

Quality management systems aligned with ISO standards

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GCP Adherence

Strict adherence to Good Clinical Practice guidelines (ICH-GCP)

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GAMP 5 Aligned

Computer system validation following GAMP 5 principles

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21 CFR Part 11

Electronic records and signatures compliance

Ready to Start Your Clinical Trial?

Contact our experts today to discuss your study requirements and how VedaRx can support your research goals.

Contact Our Clinical Team