Our specialized support addresses aunique challenges throughout the product development life cycle, ensuring a seamless experience for all stakeholders:
We provide regulatory strategy development, dossier submissions, and medical communication insights, focusing on protocol optimization and feasibility across all stages of clinical trials.
Our solutions emphasize efficient long-term follow-up and compliance with the ICH GCP guidelines and Standard Operating Procedures (SOPs).
We conduct various engagement programs to educate participants and medical professionals about the study design, protocol, inclusion/exclusion criteria, and associated benefits and risks.
Our cross-functional team expedites the development of cellular and gene therapies, with experience spanning metabolic disorders, infectious diseases, neurological disorders, cardiovascular diseases, diabetes, and pediatrics. Additionally, we have successfully supported CGT treatments that received marketing authorization, underscoring our capability to manage complex trials effectively.
Cell and gene therapies present unique operational, regulatory, and safety challenges. At Genophore Research Pvt. Ltd., our Cell and Gene Therapy division is dedicated to expediting in vivo cell and gene-based clinical trials by offering specialized operational tools, services, and leadership.
Addressing the unique needs of patients, sites, and sponsors, our end-to-end cell and gene therapy CRO solutions leverage years of experience to streamline clinical trial programs effectively. We are committed to providing comprehensive support to sponsors seeking an integrated approach to their clinical trial initiatives.
Our cell and gene therapy Contract Research Organization (CRO) capabilities are backed by expertise at every step, ensuring that our clients receive top-notch services throughout the trial process. With a proven track record of success in clinical studies involving gene and cell therapy, Genophore brings broad and deep therapeutic and functional expertise to help partners meet the demands of clinical trials.
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info@genophoreresearch.com
+91-9971734269