HingeClinica services

Our Medical and scientific Writing team is an integral part of clinical research. Our Medical Writers closely associate with biostatistics, medical affairs, safety and data management teams to deliver accurate, timely, and cost effective deliverables to the highest quality and scientific standards. We have a wide breadth of experience drawn from the pharmaceutical industry and clinical research organizations.  All documents produced by us shall undergo thorough scientific, statistical, editorial and quality control review. Our services include clinical and non-clinical writing, as well as scientific communications and medical writing consultancy.

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.

Our Clinical Data Management team has solid experience in Phase I to Phase IV clinical data management services. We are committed to providing the highest data quality, integrity, and security for our clients in meeting 21 CFR part 11, GAMP 5 and HIPAA requirements. Using industry-leading electronic data capture (EDC) technologies. We provides end-to-end clinical data management support from eCRF design to database lock and final study archival. Our processes are compliant with CDISC standards, CDASH, Controlled Terminology, SDTM, ADaM, Define-XML, and Study/Trial Design Model standards.

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.

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.

Our Project Management team has extensive experience in clinical trials project management right from the project kick-off to project closure. Our team consists of highly educated and Project Management certified professional in clinical trial end to end project management. We manage your clinical trials start from the protocol development to Final report submission. Ensuring deliverables are met within budget and on time, our project managers support Phase I-IV clinical trials across a wide variety of therapeutic indications and geographies. All project management activities are conducted in compliance with the study protocol, project management plan, standard operating procedures, ICH-GCP and all applicable regulations and guidelines.

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.