Sponsor-CRO-Site-Integrated Solutions

1) Pharmaceutical Sponsor Support

Strategic Clinical & Regulatory Partner for Sponsors

Pharmaceutical sponsors face mounting challenges, including regulatory scrutiny, rising development costs, competitive generics pressure, and global compliance expectations.

Our Sponsor-Focused Solutions:

Integrated Clinical Development Strategy

• Protocol design optimization with feasibility validation

• Statistical planning and endpoint alignment

• Risk-based monitoring framework design

• Real-world evidence strategy development

Regulatory Intelligence & Dossier Optimization

• Global regulatory submission readiness

• Bioequivalence regulatory alignment

• Gap analysis and deficiency response strategy

• Global harmonization (USFDA, EMA-aligned documentation planning)

Medical Affairs & Evidence Generation

• Post-marketing surveillance (PMS) framework design

• KOL engagement strategy

• Publication planning and medical writing oversight

• Lifecycle management advisory

Quality & Compliance Transformation

• Audits & inspection readiness

• SOP harmonization

• TMF structuring & digital oversight

• GCP compliance strengthening

Outcome for Sponsors:
Parallel and expertise guidance may result in reduced protocol amendments, faster approvals, improved data integrity, audit resilience, and optimized development costs.

CRO Operational Excellence & Partnership Enablement

Enhancing CRO Capability, Quality & Global Readiness

LEELAWMED strengthens CRO infrastructure through structured quality and operational frameworks.

Our CRO Integration Solutions:

Operational Standardization

• Harmonized SOP frameworks

• Monitoring efficiency optimization

• Site performance analytics

• Feasibility validation

Quality Assurance & Audit Preparedness

• GCP certification programs

• TMF audit simulations

• Documentation gap remediation

• CAPA design & implementation

Specialized Scientific Support

• Centralized biostatistics and study overview services

• Medical & regulatory writing

• Data cleaning & quality review

Business & Therapeutic Positioning

• Therapeutic area specialization strategy

• Capability enhancement programs

• Sponsor confidence-building documentation

Outcome for CROs:
Improved sponsor confidence, stronger audit outcomes, enhanced operational efficiency, and sustainable revenue growth.

Clinical Trial Site (Hospital & Academic Institution) Strengthening

Building Research-Ready, Industry-Aligned Trial Sites

Hospitals and academic institutions possess strong clinical expertise but often lack structured regulatory, documentation, and translational research support.

Our Site Development Solutions:

Research Infrastructure Development

• Clinical research SOP frameworks

• Ethics committee process optimization

• GCP awareness and assessment

• Regulatory documentation systems

Translational Research & IP Structuring

• Protocol development support

• Biostatistics & methodological advisory

• IP identification and commercialization pathway guidance

• Industry collaboration facilitation

Performance & Governance Models

• Study startup process acceleration

• Budget negotiation advisory

• Publication ethics and authorship structuring

• Trial site certification programs

Outcome for Trial Sites:

Improved industry collaboration, increased study allocation, enhanced compliance, and stronger publication output.