- +91-9971734269
- info@genophoreresearch.com
Our Principles
Our Principles / Why Choose Genophore?
Genophore Research offers comprehensive clinical trial services for CGT trials, covering every stage of the process. Our team is attuned to the dynamic needs of our clients and ensures adherence to regulatory standards set by national and international regulatory agencies including U.S. FDA, EMEA or DCGI, for cellular therapy.
Diverse Therapeutic Expertise
With a wealth of experience across various therapeutic areas and indications, we have conducted several CGT projects. Our research spans gene therapy, cell therapy and related modalities encompassing approximately 15 therapeutic areas including rare diseases like Huntington's disease, haemophilia, and muscular dystrophy.
Focus on Recruitment of Patients
Our ability to recruit patients efficiently is paramount. Leveraging our extensive network of hospitals and investigators, we identify locations with high enrollment potential. This ensures timely trial completion and high-quality data collection, crucial for CGT studies, which often require access to specific patient groups as well as specialized training and support resources,
Robust Quality Management
We implement and maintain rigorous quality assurance and control systems, aligned with Good Clinical Practice (GCP) and relevant regulatory requirements. Our SOPs adhere to guidelines set forth by the International Conference on Harmonization (ICH GCP), complemented by quality control practices and ISO 9001 certification. Sponsors may request audits to verify our adherence to quality management standards, handling of protocol deviations, the effectiveness of its corrective action and preventive action (CAPA) plans, and the company's ISO 9001 certification.
Commitment to Collaboration
We understand the complexities involved in organizing and executing global clinical studies, accurate analysis, and pharmacokinetics monitoring. Our commitment lies in collaborating with CGT sponsors to advance product development, ensuring thorough benefit-risk assessments.
Timely Delivery
Partnering with Genophore Research ensures the successful and timely delivery of the drug portfolios to the market, making them accessible to the global population.
We are here to assist you
Head Quarter
Advant Navis Business Park, B-806, 807, Plot # 7, Noida Expressway, Sector-142, Noida, Delhi-NCR -201305, India.
Mailing Address
info@genophoreresearch.com
Business Talk
+91-9971734269