Comprehensive Clinical
Research & Operations
End-to-end clinical development solutions connecting protocol design, patient safety, high-integrity data management, biostatistics, pharmacovigilance, and global regulatory submissions.
Clinical Research
Phase 1 - 4 Clinical Study Design & Protocol Execution
Structured clinical-development support from study planning and feasibility through study execution, data review, reporting, and close-out with strict protocol compliance.
Core Capabilities & Deliverables (6):
Phase 1 - 4 Clinical Trials
Early-phase pharmacology, proof-of-concept, confirmatory Phase 3, and Phase 4 post-marketing real-world evidence studies.
Country & Site Feasibility
Data-driven site evaluation, investigator identification, patient pool verification, and activation timelines.
Patient Recruitment & Retention
Targeted patient engagement, recruitment dashboards, and customized retention interventions.
Clinical Monitoring & Oversight
Risk-based and on-site monitoring, source data verification (SDV), and continuous protocol oversight.
Investigator Start-Up Support
Investigator meetings, site initiation visits, essential document collection, and training.
Protocol Review & Compliance
Scientific and operational feasibility review ensuring adherence to ICH-GCP E6(R2) and regional guidelines.
Clinical Operations & Project Management
A Single Operational Command Center for Study Milestones
End-to-end clinical trial governance, vendor management, timeline control, and risk mitigation to keep clinical programs on schedule and budget.
Core Capabilities & Deliverables (6):
Study Start-Up & Milestone Tracking
Comprehensive project plans, critical path management, and real-time sponsor milestone dashboards.
Site Activation & Regulatory Tracking
Ethics Committee submissions, clinical trial agreements (CTA), and greenlight release management.
Monitoring Plans & Visit Management
Standardized monitoring plans, visit report tracking, action-item closure, and centralized oversight.
Protocol Deviation Management
Proactive identification, root cause analysis, CAPA implementation, and deviation trend reporting.
Trial Supplies & Logistics
Investigational product (IP) accountability, cold-chain distribution, and depot coordination.
Close-Out & Lessons-Learned
Site close-out visits, reconciliation of study files, archiving, and lessons-learned review.
Clinical Data Management
Decision-Ready, High-Integrity Clinical Datasets
Controlled flow of clinical data from collection through validation, medical coding, reconciliation, database lock, and secure transfer.
Core Capabilities & Deliverables (6):
Data Management Plan (DMP)
Comprehensive DMP defining data flows, validation specifications, roles, and quality metrics.
CRF & eCRF Design & Annotation
User-friendly electronic Case Report Forms mapped to CDISC CDASH standards for optimal data capture.
EDC Study Build & UAT
Validated Electronic Data Capture (EDC) setup, custom edit checks, and rigorous User Acceptance Testing.
Data Validation & Query Resolution
Automated and manual edit-check review, discrepancy management, and prompt query turnaround.
Medical Coding (MedDRA & WHO)
Accurate coding of adverse events, medical history, and concomitant medications using standard dictionaries.
Database Lock & Controlled Transfer
Pre-lock data quality reviews, blinding integrity preservation, and audit-ready final data lock packages.
Biostatistics & Statistical Programming
Reliable Statistical Evidence for Regulatory Submissions
Connecting trial objectives to estimands, analysis populations, advanced statistical methodology, and publication-ready outputs.
Core Capabilities & Deliverables (6):
Statistical Consultation & Protocol Design
Early statistical input, study endpoint selection, randomization schemas, and hypothesis formulation.
Sample-Size & Power Calculations
Robust sample size estimation ensuring adequate statistical power across diverse study designs.
Statistical Analysis Plans (SAP)
Comprehensive SAP documents with mock table, listing, and figure (TLF) shells prior to unblinding.
Tables, Listings & Figures (TLFs)
Production of CDISC ADaM datasets, regulatory submission-ready summary tables, and high-res figures.
Interim Analysis & DSMB Support
Unblinded independent statistician support, charter development, and Data Safety Monitoring Board packages.
CSR Statistical Reporting
Complete statistical results write-up, sensitivity analyses, and statistical review of clinical study reports.
Pharmacovigilance & Drug Safety
Continuous Risk-Benefit Evaluation & Global Safety Compliance
Proactive safety surveillance, rapid individual case safety reporting, medical assessment, signal detection, and aggregate safety reporting.
Core Capabilities & Deliverables (6):
ICSR Intake, Triage & Processing
Rapid intake, duplicate checking, data entry, and expedited processing of spontaneous and clinical trial cases.
Medical Review & Causality Assessment
Qualified medical review assessing seriousness, expectedness, company causality, and safety narratives.
Signal Detection & Evaluation
Quantitative and qualitative signal detection, trend analysis, and safety issue escalation.
Aggregate Reports (PSUR/DSUR/PBRER)
Authoring Periodic Safety Update Reports, Development Safety Update Reports, and Benefit-Risk Evaluations.
Risk Management Plans (RMP)
Formulation of EU-RMP / REMS documents, safety specifications, and pharmacovigilance plan design.
Safety Database Reconciliation
Continuous reconciliation between clinical EDC database and safety database to ensure 100% concordance.
Regulatory Affairs
Strategic Global Submissions & Health Authority Liaising
Strategic regulatory pathways, dossier gap assessments, IND/NDA compilation, authority correspondence, and lifecycle maintenance.
Core Capabilities & Deliverables (6):
CTD / eCTD Dossier Compilation
End-to-end authoring and publishing of electronic Common Technical Document (eCTD) modules.
IND & Clinical Trial Applications (CTA)
Preparation and submission of regulatory dossiers to CDSCO, US FDA, EMA, and national authorities.
Health Authority Interactions
Meeting request packages, briefing documents, authority presentation support, and correspondence logs.
Deficiency & Query Responses
Rapid turnaround on authority information requests, scientific justifications, and dossier amendments.
Post-Approval Variations & Lifecycle
CMC variations, site transfers, label harmonization, and periodic regulatory maintenance.
Inspection & Audit Readiness
Mock regulatory audits, trial master file (TMF) reviews, and regulatory compliance gap closures.
Medical & Scientific Writing
Clear, Submission-Ready Scientific Communication
Connecting subject-matter expertise with regulatory standards to produce publication-quality clinical, regulatory, and academic documents.
Core Capabilities & Deliverables (6):
Clinical Study Protocols & Amendments
Well-structured protocols adhering to ICH E6 guidelines with clear objectives, estimands, and procedures.
Investigator's Brochures (IB)
Concise summary of pre-clinical and clinical data supporting study design and risk-benefit evaluation.
Clinical Study Reports (CSR - ICH E3)
Comprehensive, submission-ready CSRs integrating clinical, medical, and statistical findings.
Patient Materials & Informed Consent
Clear, patient-friendly informed consent forms (ICFs), assent forms, and patient education brochures.
Manuscripts & Publication Support
Drafting scientific manuscripts, abstracts, posters, and conference presentations for peer-reviewed journals.
Literature Reviews & Meta-Analyses
Systematic literature searches, clinical overview summaries, and evidence-based clinical evaluations.
Clinical Research Delivery Lifecycle
Feasibility
& Design
Set-up
& Regulatory
Site Activation
& Recruitment
Monitoring
& Oversight
Database Lock
& Analysis
CSR &
Close-out
Discuss Your Clinical Trial Requirements
Collaborate With Our Clinical Operations, Biostatistics & Regulatory Specialists
Stay connected with science
Stay connected with scienceStay Informed. Stay Ahead in Research.
Subscribe to receive the latest updates on pharmaceutical research, clinical and pre-clinical testing, medical device safety, regulatory developments, scientific insights and industry events from Ribosome Research Centre.