Sunilkumar P

• Pharma & Research Collaboration – Partnering with pharmaceutical companies, CROs, and research networks to design digitally regulatory-ready studies
• Database Mapping & Clinical Coding – Standardizing clinical data across multiple domains for structured analysis and interoperability
• Digital Trial Implementation – Transforming trial protocols into digital execution packages, ensuring I/E criteria alignment
• Patient e-Screening & Cohort Development – Leveraging automated screening to build optimized study cohorts
• Regulatory Compliance & GCP Standards – Ensuring adherence to Good Clinical Practice (GCP) guidelines in digital trials
• AI, NLP & ML Model Validation – Enhancing clinical trial processes through data-driven insights & AI-powered automation
• Software Innovation & User Training – Supporting the development and adoption of clinical trial optimization platforms, Bridging clinical research, informatics, and AI to accelerate digital clinical trials & enhance patient outcomes.

Clinical Trials Informatics | Digital Trial Optimization & Data Standards

• Key Expertise & Responsibilities:
• Clinical Trial Digitalization – Ensuring compliance with Good Clinical Practice (GCP) guidelines
• Study Protocol Review – Analyzing inclusion/exclusion criteria, adverse events, hospitalizations, and medication data
• Clinical Data Standardization – Mapping eCRFs, EMRs, and EDCs using informatics principles
• Cross-Functional Collaboration – Working with engineers, data scientists, clinical stakeholders, and clients
• Terminology & Data Modeling – Expertise in clinical data standards, terminologies, and internal data models
• Data Quality & Validation – Developing quality checks to ensure high-quality real-world data pipelines
• SOP & Product Development – Assisting in the creation of Standard Operating Procedures (SOPs)
• Clinical Trial Optimization – Supporting the innovation of digital trial solutions & software suites

Clinical Terminology & Knowledge Management | Healthcare Data Standards

Core Competencies:

• Clinical Data Mapping & Aggregation – Standardizing and integrating clinical data for Cerner solutions

• Key Responsibilities & Expertise:
• Healthcare Quality Measures & Registries – Working with HEDIS, ACO, MIPS, and Clinical Standards
• Clinical Content Configuration – Enabling/disabling & configuring measures in CSV4 Clinical Standard
• Terminology Development – Creating new concepts using the Discern Ontology Tool
• Cross-Functional Collaboration – Partnering with onboarding teams, managers, and client-facing consultants
• Clinical Standard Catalogues – Managing and maintaining registry content and client-facing wiki pages
• Agile & Issue Management – Slotting, tracking JIRA tickets, and working on sprint boards
• Troubleshooting & Incident Management – Ensuring service KPIs & client support resolution

• Terminology Expertise – Hands-on experience with LOINC & SNOMED CT, RxNorm International
• Interoperability & EMR Integration – Developing terminology content for rules, registries, analytics, and applications
• Terminology Review & Quality Assurance – Validating client proprietary codes and industry-standard mappings
• Multi-Standard Mapping – Designing mappings across laboratory, problems/ diagnoses, units of measure, and person data
• Clinical Decision Support (CDS) – Facilitating accurate interpretation & exchange of clinical information
• Technical Proficiency – Working knowledge of SQL queries, JIRA workflows, and Tableau report interpretation
• Training & Mentorship – Onboarding new associates in Laboratory terminology mapping & workflows
• Cross-Team Collaboration – Supporting HealtheIntent deployments into EMR & EHR systems

• Key Responsibilities & Expertise:
• Pathology Education & Training – Delivering lectures, seminars, and lab sessions on General Pathology, Histopathology, Haematology, and Clinical Pathology
• Curriculum Development – Creating engaging teaching materials, presentations, and practical demonstrations to enhance student learning
• Student Assessment & Mentorship – Designing exams, quizzes, and assessments while mentoring allied health students in pathology applications
• Collaborative Curriculum Enhancement – Working with faculty members to update content with modern pathology advancements
• Hands-On Laboratory Supervision – Overseeing specimen collection, preparation, and analysis in pathology labs
• Academic Guidance & Support – Providing continuous feedback and counseling to foster student growth
• Keeping Up with Advances in Pathology – Integrating latest healthcare developments into teaching methodologies

• Key Responsibilities & Expertise:
• Advanced Diagnostic Testing – Performing CBCs, blood smears, reticulocyte counts, and coagulation studies to detect blood disorders such as anemia & leukemia
• Sample Management & Processing – Collecting, preparing, and processing blood samples while ensuring proper documentation & traceability
• Inventory & Sample Storage – Managing laboratory inventory, reagents, and consumables while ensuring proper storage of blood samples for future testing and research
• Quality Control & Equipment Maintenance – Implementing strict QC procedures and maintaining laboratory equipment for accuracy & reliability
• Data Analysis & Reporting – Interpreting results and generating
• comprehensive reports for pathologists & clinicians
• Collaboration & Patient Communication – Working closely with healthcare teams to provide insights and ensuring patients understand procedures
• Regulatory Compliance & Safety – Adhering to infection control measures and accreditation standards in laboratory operations
• Continuous Learning & Innovation – Staying updated with haematology advancements & lab technology through ongoing education

Project: Case-Control study ( Hypertension) , BCS - Birth Cohort Study

Key Expertise & Responsibilities:

• Patient Preparation & Sample Collection – Guiding patients through pre- test procedures, conducting blood draws, and ensuring proper questionnaire documentation
• Sample Management & Processing – Collecting, preparing, and processing blood samples while ensuring proper documentation & traceability
• Clinical & Biochemical Analysis – Performing biochemical, hormonal, and clinical pathology investigations for accurate disease diagnosis
• Advanced Laboratory Testing – Utilizing cutting-edge techniques for blood sample analysis & result interpretation
• Sample Storage & Integrity – Managing proper storage protocols for future testing and research consistency
• Quality Assurance & Compliance – Adhering to strict laboratory standards, safety protocols, and accreditation guidelines