Clinical Research Projects

Please choose one of the thrust areas mentioned below or let us know your interested area of project work.

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Protocol synopsis and full protocol development for Phase I–IV
Data-driven feasibility and site selection strategy
eConsent implementation and compliance verification
EDC build, edit check programming, and validation
CRF design aligned to CDASH standards
CDISC SDTM and ADaM mapping specifications
Randomization schema and IWRS strategy
Risk-based quality management (RBQM) and monitoring plans
Decentralized and hybrid trial operations blueprint
ePRO and eCOA instrument selection and validation support
Wearables and digital biomarker integration pipelines
Data cleaning, query management, and KPI dashboards
Statistical analysis plan (SAP) outline and shells
Sample size and power calculations with sensitivity analysis
Medical writing: CSR shells, IB updates, and protocols
PK/PD data integration and popPK overview workflows
Quality management system SOP drafting for GCP
Vendor qualification, oversight, and audit readiness
21 CFR Part 11 and Annex 11 validation documentation
eTMF structure, indexing, and inspection readiness
Clinical supplies forecasting and IXRS strategies
Patient recruitment and retention digital strategies
Site initiation and GCP training programs
DSMB charter drafting and safety monitoring workflows
Signal detection interface between PV and CT operations
Device trial planning according to ISO 14155
Special populations: pediatric and geriatric considerations
Multicenter coordination and communication frameworks
Publication-ready TLFs and CSR QC processes
Operational risk assessment and mitigation playbooks

Below are some focused areas that are more research-oriented, designed to help you dive deeper and explore advanced aspects.

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Adaptive designs: group sequential and sample size re-estimation
Bayesian trial design and prior specification strategies
Platform, umbrella, and basket master protocols
Causal inference with real-world data and target trial emulation
Survival analysis beyond Cox: AFT and cure models
Missing data strategies: multiple imputation and IPW
Multiplicity control: gatekeeping and FWER/FDR procedures
Estimands framework implementation (ICH E9 R1)
Psychometrics for PRO and HRQoL endpoints (IRT models)
Digital biomarker validation and analytical qualification
Bias and variance in decentralized trials: assessment methods
Signal processing for wearable-derived endpoints
Graphical alpha spending and sequential testing
Simulation of master protocols and decision rules
Pharmacometric to pharmacoeconomic model integration
Synthetic control arms using registries and RWD
N-of-1 and small-sample trial methodologies
Cluster randomized and stepped-wedge trial designs
Crossover and bioequivalence advanced statistics
Network meta-analysis and Bayesian hierarchical models
External data borrowing with commensurate priors
Multi-regional clinical trials heterogeneity analysis
Patient stratification with ML and fairness evaluation
Calibration drift in ML-enabled screening RCTs
RWD quality frameworks aligned to regulatory guidance
Recruitment and dropout simulation under constraints
Differential privacy for shared clinical datasets
Imaging endpoints: automation and RECIST validation
Pediatric extrapolation and bridging strategies
Pragmatic trial design and PRECIS-2 scoring

Below focused areas below are not just for researchers — they are also practical and useful for government organizations.

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National clinical trial registries and data standards
Ethics committee accreditation and quality oversight
GCP inspection readiness programs and auditor training
Post-marketing surveillance and active safety systems
Vaccine safety surveillance and AEFI analytics
Pharmacovigilance signal detection at population scale
Health technology assessment modeling guidelines
Clinical trial transparency and data sharing policies
Real-world evidence frameworks for coverage decisions
Standardization of eConsent and privacy safeguards
Capacity building for sites in underserved regions
Protocol scientific review and turnaround optimization
Rare disease and orphan trial policy frameworks
Pediatric research protections and assent guidance
Rapid ethics review for public health emergencies
Interagency data linkage for outcomes research
Guidance for digital health and SaMD clinical evaluation
Registry-based randomized trial policy development
Biobanking governance and dynamic consent models
Diversity, equity, and inclusion enrollment targets
Monitoring algorithmic bias in recruitment tools
National eTMF archive and retention standards
Cloud and cybersecurity standards for EDC and IWRS
Public dashboards for ongoing trials and results
Continuity planning for trials during crises
International harmonization with ICH and WHO
Guidance on AI-assisted analyses and medical writing
SOP templates for investigator-initiated studies
Oversight for compassionate use and expanded access
Outcome-based reimbursement pilots using RWE

Few more focused areas for those who can push boundaries.

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Federated learning across hospitals without data sharing
Privacy-preserving record linkage and PPRL methods
Digital twin patients for trial simulation and planning
Open-source adaptive platform trial toolkits
Smartphone-based passive sensing outcome measures
Voice biomarkers for mental health clinical studies
Computer vision pipelines for imaging endpoint extraction
Synthetic clinical data generation and validation
Wearable adherence detection and bias mitigation
NLP for AE coding and MedDRA mapping automation
Real-time quality monitoring with anomaly detection
Bayesian decision-theoretic stopping rules
Multi-omics patient stratification and integrative analysis
Reinforcement learning for dose titration strategies
eSource integration via FHIR and interoperability studies
FAIR data stewardship for clinical research
Bias and fairness audit frameworks in ML-supported trials
Explainability methods for clinical decision support tools
Causal discovery from EHR longitudinal data
Rare disease small-sample design catalog and toolkits
Estimand sensitivity simulation frameworks
Robust analyses under protocol deviations
Patient-centered trial co-design methodologies
Gamified retention interventions and A/B testing
Quality-by-design templates and case libraries
Pragmatic–explanatory hybrid trial methodologies
Decentralized informed consent UX research
Real-time adjudication platforms with consensus models
Interactive dashboards for teaching clinical statistics
Open datasets curation for benchmarking trial methods

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