services
Clinical research & public health solutions, scientific, operational, & analytical support.
Project Management & Programmatic Support
Clinical Project Management
- Design and maintenance of project timelines, milestones, and deliverable tracking systems
- Cross-functional coordination across multi-site clinical networks
- Budget development, management, and financial reporting
- Proactive risk identification, assessment, and mitigation planning
- Stakeholder communication, status reporting, and issue escalation
- Vendor selection, onboarding, and ongoing partner coordination
Programmatic Support
- Strategic planning and oversight for multi-study research programs
- Facilitation of multi-institution collaborations and consortium management
- Research governance oversight, including committee coordination and reporting
- Program milestone tracking and performance monitoring against key indicators
Project Management Advisory
- Design and implementation of clinical research management frameworks
- Operational strategy development for research programs and networks
- Quality management system (QMS) design and continuous improvement
- Research governance structure development and policy guidance
- Process mapping and workflow optimisation to improve operational efficiency
Training & Capacity Building
- Hands-on protocol implementation training for site and coordinating centre staff
- Standard Operating Procedure (SOP) development, review, and training delivery
- Manual of Procedures (MOP) development tailored to study-specific requirements
- Good Clinical Practice (GCP) training compliant with ICH E6(R2) guidelines
- Research ethics, informed consent, and regulatory compliance training
- Data collection, entry, and quality management training for clinical teams
Grant Development & Scientific Writing
Grant and Proposal Development
- Hypothesis generation, concept development, and study design consultation
- End-to-end proposal writing, editing, and scientific review
- Budget development, cost justification, and financial narrative preparation
- Coordination of multi-institution submissions, including subcontract management
- Ensuring compliance with funder-specific requirements, formatting, and deadlines
Protocol Development
- Articulation of study objectives, research questions, and primary/secondary hypotheses
- Study design selection and methodology development (interventional and observational)
- Eligibility criteria development and study population characterisation
- Data collection instrument design and data flow documentation
- Ethical considerations, including risk-benefit analysis and participant protections
- Preparation of regulatory submission packages (IND, IDE, ethics committee applications)
Manuscript Development
- Full scientific manuscript writing from draft to submission-ready versions
- Data interpretation, results synthesis, and discussion framing
- Target journal selection, formatting compliance, and cover letter preparation
- Design and production of publication-quality tables, figures, and supplementary materials
- Structured response to peer reviewer comments with tracked revision documentation
Clinical Trial Implementation
Study Start-Up
- Site feasibility assessments, including infrastructure and patient population evaluation
- Site selection, qualification, and formal evaluation against study criteria
- Ethics committee and institutional review board (IRB) submissions and amendments
- Regulatory authority submissions and approval management
- Clinical trial agreement (CTA) and budget negotiation and execution
- Site initiation visits, staff training, and study activation
Study Operations
- Development and execution of participant recruitment and retention strategies
- Day-to-day study coordination across single and multi-site networks
- Ongoing monitoring, compliance tracking, and protocol deviation management
- Investigational product and study supply management, including chain of custody
- Operational logistics planning for complex or resource-limited settings
Quality Assurance
- Risk-based and on-site monitoring visits with detailed findings reports
- Protocol compliance monitoring and deviation trending
- Data quality oversight and source document verification
- Audit readiness preparation and support during regulatory inspections
Data Management Solutions
Study Database Development
- Electronic data capture (EDC) system design, build, and validation (REDCap)
- Electronic case report form (eCRF) development with built-in edit checks and data validation rules
- Scalable database architecture for complex, multi-site, and longitudinal studies
Data Management
- Data cleaning, discrepancy identification, and query management workflows
- Data harmonisation across sites, time points, and disparate collection systems
- Implementation of secure data storage, access controls, and audit trail management
- Data transfer, mapping, and integration with third-party systems and repositories
Data Quality Assurance
- Programmatic data validation checks and automated consistency reviews
- Real-time data monitoring dashboards for site and sponsor oversight
- Data lock procedures, database freeze protocols, and formal database closure documentation
Biostatistics & Data Analytics
Study Design
- Randomised controlled trial (RCT) design, including allocation concealment and blinding strategies
- Observational study design: cohort, case-control, cross-sectional, and registry-based approaches
- Adaptive trial designs, platform trials, and master protocol frameworks
Sample Size & Power
- Power calculations for superiority, non-inferiority, and equivalence hypotheses
- Sensitivity and scenario analyses to evaluate robustness of sample size assumptions
- Intraclass correlation coefficient (ICC) estimation and cluster-adjusted sample size calculations
Statistical Planning
- Statistical Analysis Plan (SAP) development in accordance with ICH E9 and E9(R1) guidelines
- Table, Figure, and Listing (TFL) shell development and mock output preparation
Data Analysis
- Multivariable regression analysis (linear, logistic, Poisson, negative binomial)
- Time-to-event and survival analysis (Kaplan-Meier, Cox proportional hazards)
- Longitudinal data modelling using generalised estimating equations (GEE) and mixed-effects models
- Bayesian analysis, including prior specification, posterior estimation, and credible interval reporting
- Systematic review and meta-analysis, including heterogeneity assessment and publication bias evaluation
Management, Compliance, Monitoring, Integration, Analytics, Academic
Site Management & Monitoring
- Site selection, qualification, and capability assessments
- Site initiation visits to ensure readiness prior to first patient enrollment
- Routine and close-out monitoring visits with written reports
- Ongoing site performance evaluation against enrollment, data quality, and compliance metrics
- Investigator and site staff support, including issue resolution and protocol guidance
- Development and oversight of corrective and preventive action (CAPA) plans
Regulatory Affairs & Compliance
- IRB and ethics committee submissions, amendments, continuing reviews, and closure notifications
- DCGI (Drugs Controller General of India) submissions, including CT applications and regulatory correspondence
- HMSC (Health Ministry Screening Committee) submissions for studies involving foreign collaboration or funding
- Regulatory strategy and compliance oversight in accordance with Schedule Y, GCP guidelines, and ICH standards
- Regulatory documentation management, including investigator site files and trial master files (TMF)
- Inspection readiness, preparation and support during regulatory authority audits
Pharmacovigilance & Safety Monitoring
- Development of safety monitoring plans and safety management frameworks
- Adverse event (AE) collection, assessment, and reporting per protocol and regulatory requirements
- Serious adverse event (SAE) processing, narrative writing, and expedited reporting
- Ongoing safety data review, signal detection, and aggregate safety reporting
- Data Safety Monitoring Board (DSMB) coordination, charter development, and meeting support
- Risk evaluation and mitigation strategy (REMS) development and implementation support
Laboratory & Biomarker Integration
- Central and local laboratory coordination, including selection, qualification, and oversight
- Biomarker analysis strategy development aligned with study endpoints and regulatory expectations
- Sample collection protocol design, processing instructions, and cold chain management
- Biobanking support, including long-term repository planning
- Integration and harmonization of laboratory data with clinical datasets for unified analysis
Digital Health & AI Analytics
- Design and implementation of digital data capture systems, including ePRO and wearable device integration
- Real-world data (RWD) integration from electronic health records (EHR), claims, and registries
- Data privacy, security, and regulatory compliance for digital health applications (21 CFR Part 11, GDPR)
Study Dissemination & Knowledge Translation
- Peer-reviewed scientific publication planning, writing, and submission management
- Policy briefs and evidence summaries tailored for government, funder, and public health audiences
- Technical reports, study closeout summaries, and sponsor deliverable documentation
- Abstract development and oral or poster presentation preparation for scientific conferences
- Stakeholder and community engagement strategies to maximise research impact and uptake