Our Services

• Client Requirement & Vision – Understanding goals, key services, and long-term objectives.

• Project Scope – Defining infrastructure, regulatory needs, and operational focus.

• Market Research & Competitive Analysis – Evaluating industry trends, demand, and potential clients.

• Business Model Strategy – Identifying the best operational model (Standalone CRO, JV, or Strategic Partnership).

• Budget Planning & Financial Structuring – CAPEX & OPEX estimation, ROI projections, and investment strategies.

• Cost Optimization & Financial Discussions – Minimizing setup costs while ensuring compliance and quality.

CRO Setup Services

Feasibilty Analysis & Cost Planning

Infrastructure Development

• Architectural Layouts & Lab Design – Structuring Clinical, Bioanalytical, and Administrative spaces for efficient workflow.

• IT Infrastructure Setup – Implementing secure LAN, Servers, Intercom, high-speed Internet, and Cloud-based Systems.

• Data Backup & Cloud Management – Ensuring secure data storage, retrieval, and regulatory compliance.

• Fire Safety & Security Systems – Installing CCTV surveillance, fire alarms, and emergency response systems.

• Power Backup & Redundancy – Setting up UPS, generators, and alternative power solutions to prevent downtime.

• Electrical Infrastructure – Designing efficient power distribution systems, conducting electrical safety audits, and ensuring compliance with regulatory power standards.

Quality Management System

• Regulatory Application Submission – Preparing and submitting applications to NAFDAC, CDSCO, USFDA, EMA, MHRA and Ethics Commitees for facility approvals and study conduct.

• Standard Operating Procedures (SOPs) – Developing and Implementing SOPs for Clinical, Bioanalytical, Quality, and Operational workflows in compliance with regulatory standards.

• Quality Management System (QMS) Implementation – Establishing and Ensuring infrastructure, instrumentation, and workflows meets 21 CFR Part 11 guidelines, GCP, GLP, and GMP-compliant systems for consistent quality and regulatory adherence. 

• Regulatory Documentation & Readiness – Preparing all necessary records, compliance checklists, and risk mitigation plans for seamless approvals.

• Pre-Audit Compliance Checks – Conducting internal audits, gap analysis, and corrective action plans before regulatory inspections.

• Audits - Support for Regulatory and Sponsor Audits. Handling Gap Analysis, Compliance Corrections and Audit Queries.

Human Resource & Training

• Hiring of key personnel – Recruitment of Department Heads, Bioanalytical Scientists, Clinical team, Quality assurance personnel, and other technicians with relevant expertise.

• Regulatory & SOP training – Conducting GCP, GLP and GDP training, ensuring compliance with regulatory guidelines and In-House SOPs.

• Instrument Handling & Operational training – Hands-on training for Analytical Instruments, Clinical Equipment, and Bioanalytical softwares to ensure accuracy and efficiency.

• Quality assurance & compliance training – Educating QA teams on Audits, Deviations, CAPA (Corrective and Preventive Actions), and regulatory inspections.

• Clinical Team training – Comprehensive training on Subject Screening, Study Conduction, eCRF usage, and regulatory documentation.

• Selection of Clinical and Bioanalytical Instruments – Identifying and sourcing required instruments, both new and refurbished, based on project needs and budget.

• IQ, OQ, PQ qualification – Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure regulatory compliance.

• Calibration & Preventive Maintenance – Developing annual schedules for instrument calibration and preventive maintenance to ensure accuracy and reliability.

• Vendor negotiations & management – Negotiating Annual Maintenance Contracts (AMC) and warranty agreements for long-term equipment upkeep. Procurement and Sourcing with vendors for Instruments, Clinical and Lab consumables, Reagents, Working Standards, and Analytical Columns.

Instrument Precurement & Vendor Management

• Study Protocol preparation – Developing regulatory-compliant protocols for clinical and bioanalytical studies.

• Clinical & Bioanalytical project execution – Ensuring smooth study conduct, from subject screening to Bioanalytical Mathod Development and Validation with Subject Sample Analysis.

• On-site & remote monitoring – Implementing robust monitoring systems to track study progress, ensuring compliance and data integrity.

• Risk management & Troubleshooting – Identifying potential challenges and implementing corrective measures for uninterrupted workflow.

• Biostatistics & Data Processing – Applying advanced statistical methods for Pharmacokinetic and Bioequivalence analysis.

• Regulatory-compliant Reporting – Preparing high-quality reports for regulatory submission, ensuring accuracy and compliance with global standards.

Operations & Study Monitoring

Clinical Research Services

Bioavailability / Bioequivalence Studies

• Protocol Development – Designing study protocols as per regulatory guidelines (FDA, EMA, CDSCO, NAFDAC etc.).

• Regulatory Support – Preparing and submitting dossiers for study approvals.

• Clinical & Bioanalytical Execution – Managing subject recruitment, sample collection, and bioanalysis.

• Pharmacokinetic & Statistical Analysis – Evaluating drug absorption, distribution, metabolism, and elimination.

• Report Preparation & Submission – Compiling study reports for regulatory submissions and approvals.

Pre-Clinical (Animal) Studies

• Study Design & Protocol Development – Designing animal studies for pharmacokinetics, toxicology, and efficacy evaluation.

• Animal Model Selection & Study Execution – Identifying appropriate animal models and conducting experiments.

• Regulatory & Ethical Compliance – Ensuring adherence to CPCSEA, OECD, and other regulatory guidelines.

• Bioanalytical & Statistical Data Analysis – Conducting pharmacokinetic, toxicology, and histopathological assessments.

• Report Writing & Submission – Preparing study reports for regulatory filings and scientific publications.

Clinical Trials

• Clinical Trial Design & Planning – Developing study protocols, case report forms, and clinical trial management plans.

• Regulatory Approvals & Compliance – Securing approvals from ethics committees and regulatory agencies.

• Site Selection & Investigator Coordination – Identifying trial sites and managing investigator communications.

• Patient Recruitment & Monitoring – Overseeing patient enrollment, safety monitoring, and data collection.

• Data Analysis & Reporting – Performing statistical analysis and preparing clinical study reports (CSRs).

Medical Writing

• Regulatory Writing – Preparing documents such as Clinical Study Reports (CSR), Investigator Brochures (IB), and Common Technical Documents (CTD).

• Scientific & Manuscript Writing – Writing research papers, literature reviews, and white papers for publication.

• Protocol & Study Document Preparation – Developing protocols, informed consent forms, and case report forms.

• Pharmacovigilance Writing – Preparing safety reports, Periodic Safety Update Reports (PSUR), and Risk Management Plans (RMP).

• Medical Communication & Training Materials – Developing training manuals, presentations, and healthcare content.

Biostatistics

• Study Design & Sample Size Calculation – Ensuring statistically sound research methodologies.

• Statistical Analysis Plan (SAP) Development – Designing detailed plans for data analysis.

• Clinical & Pre-Clinical Data Analysis – Performing inferential statistics, modeling, and data interpretation.

• Regulatory Compliance & Reporting – Preparing statistical reports for regulatory submissions.

• Data Management & Visualization – Organizing clinical trial datasets, developing graphical reports, and ensuring data integrity.

Calibration Services

• Calibration & Validation – Ensuring precision and accuracy of laboratory instruments.

• Compliance with Regulatory Standards – Adhering to GLP, GMP, ISO, and other regulatory requirements.

• Routine Performance Verification – Conducting periodic checks and preventive maintenance.

• Audit Support & Documentation – Preparing calibration reports and supporting regulatory inspections.

• Troubleshooting & Optimization – Identifying and resolving instrument performance issues.

Softwares & IT Services

OV eCRF: Software for Volunteer Management. Digital way of registration and screening of volunteers for Clinical Trials and BA/BE studies. Totally 21 CFR complient software with Block/ Unblock feature and identification of Repeating Volunteers.

OV Docs: Software for Documentation Management. Handle SOP & document preparation, issuance, review, and approval with strict version control. Controlled and uncontrolled copies are reconciled to ensure accountability.

OV Talent: Software for Employee Training. Covering orientation, assessments, on-the-job, group training, GxP compliance, a planner, job responsibilities, and CV tracking, while also maintaining detailed training records.

OV Track: Software for Quality Management. Manage change control, incident management, CAPA, deviation tracking, risk management, OOS, OOC, and OOT analysis for streamlined compliance in regulated environments.

OV Eye: Software for Audit Management. Efficiently manage various audits, including internal, regulatory, vendor, project and other audits, while also tracking observations and compiling records for compliance.

OV Labs: Software for Laboratory Information Management (LIMS). Streamlines sample tracking, analytics, and result generation while integrating seamlessly within instruments, OV Caliber, and OV Log, ensuring robust laboratory management.

OV Sign: Software for Digital Signature. Easily digitally sign documents yourself or seamlessly send documents for signature collection from anyone, simplifying the signing process and facilitating efficient document management.

OV Caliber: Software for Instrument Data Management. The software efficiently handles instrument records, schedules, activities (Installation, calibration, PM, Break down, discontinue), planners, and customizable labels.

OV Log: Software for Electronic Logbook. Design a logbook template with real-time data management, compliance tracking, and rolebased access control for effortless use. Ensure Instrument and Other Logbook entries effortlessly.

OV Saga: Software for Archival Management. Manage archived documents, samples, and data backups within the software, enabling users to designate archive locations and track the movement of archived data.

OV iBook: Software for Inventory Management. The software allows users to request materials, manage issuance, and customize labels, purchase orders (PO), and goods received notes (GRN) for streamlined inventory management.

Excel Sheet Validation: Validating spreadsheets for regulatory and compliance purposes to ensure data integrity and accuracy.

Computer System Validation (CSV): Assessing and validating software systems, ensuring compliance with FDA 21 CFR Part 11, GAMP 5, and other regulatory standards.

Data Backup and Cloud Services: Providing secure data storage, backup, and recovery solutions for research, clinical, and regulatory data protection.