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Company description

Innovate Research is an Indian contract research organization (CRO) headquartered in Noida, Uttar Pradesh, providing services across clinical research, regulatory affairs, quality assurance, and data management. The organization supports clients from Phase I first-in-human studies through to Phase IV post-marketing trials, and has worked with more than 150 international and domestic clients across more than 22 therapeutic areas, completing over 250 studies across all phases.

Innovate Research serves a broad range of industries, including pharmaceuticals (small and large molecules), biologicals and biotechnology, medical devices and medtech, food and beverages, nutraceuticals, herbals, FMCG, cosmeceuticals, and cosmetics. The organization caters to multiple regulatory agencies and supports submissions in electronic Common Technical Document (eCTD) format, including IND, NDA, and IDE preparation.

Industries Served

• Pharmaceuticals (Small Molecules and Large Molecules)
• Biologicals and Biotechnology
• Medical Devices and Medtech
• Food and Beverages
• Nutraceuticals, Herbals, and FMCG
• Cosmeceuticals and Cosmetics

Scientific Areas and Service Coverage

• Clinical Research Phase I through Phase IV
• Real World Evidence (RWE), Health Economics and Outcomes Research (HEOR), and Post-Marketing Observational Studies (PMOS)
• Clinical Data Management
• Interactive Web Response System (IWRS)
• Regulatory Affairs and Support
• Quality Assurance
• Biostatistics
• Medical Writing
• Project Management
• Clinical Monitoring
• Site Management
• Study Feasibility
• Biospecimen Collection

Key Service Capabilities

• Study Feasibility: Identifies suitable clinical sites through in-depth research and feasibility assessments to match project requirements.
• Medical Writing: An experienced team of medical writers handles projects ranging from initial protocol development to clinical study reports and final regulatory documentation.
• Regulatory Support: Services span from advisory consulting to full preparation and submission of IND, NDA, and IDE applications, including eCTD-format submissions.
• Clinical Monitoring: Dedicated clinical research associate (CRA) teams provide investigator site support and data oversight; CRAs are required to demonstrate site monitoring proficiency before assignment to a study.
• Project Management: Full-service project management is provided for Phase I through Phase IV trials across major therapeutic areas, drawing on formal training and hands-on experience with pharmaceutical and device trials.
• Biostatistics: A team of biostatisticians and statistical programmers delivers services including sample size calculations, randomization schedule generation, and blinding and unblinding procedures.
• Biospecimen Collection: A network of hundreds of sites across India supports procurement for research laboratories, diagnostic companies, medical device firms, and pharmaceutical manufacturers.
• Insourcing and Outsourcing: A recruitment team with scientific backgrounds specializes in identifying and placing scientific and functional candidates for clinical research roles.
• Data Management: Clinical data management processes and technology are applied across Phase I–IV trials in a wide range of therapeutic areas to improve accuracy and efficiency.
• IWRS: Innovate Research offers an in-house developed Interactive Web Response Management System called PageOne, provided as part of its eClinical portfolio.
• Site Management: The site management organization (SMO) team works to bridge the gap between sites and sponsors or CROs, supporting patient enrollment and trial management from start to finish.
• RWE and HEOR: The organization gathers real-world data through claims and medical record review and communicates findings to support value demonstration for life sciences clients.

Clinical Trial Delivery

• Supports early-phase testing through a database of hospital-based clinical units.
• Rapid participant recruitment is facilitated via an in-house database and established relationships with leading hospitals.
• Each study is assigned a dedicated project team comprising project management, regulatory, quality, and scientific specialists.
• Studies are conducted in modern clinical facilities.
• The organization has conducted Phase I trials on IND molecules, with more than four such studies completed.

Innovate Research holds relevant certifications and accreditations and operates from its office in Sector 2, Noida, Uttar Pradesh. The organization can be contacted via email at [email protected] or by phone at +91 7999822780.

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Software attributed to Innovate Research

• ClinSoftView
• PageOne IWRSView

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