HingeClinica
8 services found

HingeClinica services

Safety Reporting & Pharmacovigilance Services

Our Pharmacovigilance team has global experience in safety reporting in clinical trials and post marketing surveillances. Our team consists of highly educated, professional with medical, pharmacology background and having in-depth knowledge in using various safety databases, safety reporting requirements, Pharmacovigilance regulations and guidelines.

Regulatory Consulting Services

HingeClinica providing regulatory consulting services to Pharmaceutical, Biotechnology, and API manufacture and medical devices.

Biostatistics & SAS Programming Services

Our Biostatistics & SAS programming team has global experience in clinical trials start right from the protocol design to Final analysis. Our team consists of highly educated, professional with Biostatics and SAS programming and has in depth knowledge in ICH GCP, ICH E9, CDISC, CDASH and SDTM standards. We offer full range of integrated, global, therapeutically aligned Biostatistics services for clinical development planning, execution, and analysis across all phases of the development.

Medical Device Services

HingeClinica is a world class partner for Medical Device services. We render End to End Medical device MDR compliance and Regulatory services, Clinical trial, Pharmacovigilance services to Medical Devices industry. Our Medical Device team has extensive experience in working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW, regulatory Submissions and liaisoning.

Clinical Trial Management Services

Our clinical operations teams have extensive experience in conduct of multicentric global clinical trials in various therapeutic areas. Our team consists of experienced Clinical Managers, CRAs, Medics, Pharmacologists with excellent medical background and in-depth knowledge on clinical trial regulations and ICH GCP guidelines. We strive to be responsive, flexible and mindful throughout the trial and site management process; looking for innovative ways to improve subject recruitment and retention, site productivity and timely completion of clinical trials.