Astraclinical is a visionary Clinical Research Organization which provides end to end comprehensive clinical data management services from Phase I through to post-marketing trials. We offer an end-to-end Clinical Data Management solution including, rapid database launch; integrated clinical data sources; expert medical coding, query management and resolution, effective external vendor data management, database lock; and clean, quality clinical trial data.
Astraclinical takes care complete product life cycle starting from clinical trial data management, compilation and filling of dossier for new product approval, product management for successful product launch followed by pharmacovigilance compliance to check adverse drug reaction and finally medical communication to keep abreast patients and physicians.
Our expertise and experience team focus on achieving full commercial potential for all services. Our team has proven ability to advise and manage a variety of projects of all sizes. We have list of satisfied clients from across the world. We are connected with global Pharma fraternity because we are chief organizer of Pharma Ratna Universe. Pharma Ratna Award is a Pharma frontier award for global community.
Systematic Product Life Cycle begets successful brand. Hence we have to understand that only clinical trial data is not the main step of product life cycle. Yes clinical trial data is the first step of product life cycle to check safety and efficacy of product along with adverse drug reaction in a limited population. Second step is regulatory compliance to get the product registered by compiling dossier. Third step is product management means designing launch strategy that includes prelaunch, post launch and relaunch. Forth step is pharmacovigilance to check adverse drug reaction after launch of the product. Fifth step is regular medical communication with patients, physicians and national and international pharmacovigilance centers.
We are your perfect partner for Clinical Data Management, Regulatory Management, Product Management, Pharmacovigilance and Medical Communication. You will get complete solution for your product from initiation to development and growth to maturity. We are expertise in giving you back quality clinical data and then we can compile and file e-CTD dossiers.
Pharmacovigilance is now utmost important in almost all countries of the world to take care patient first and then product life cycle. We can support in compiling Independent Case Study Report, Periodic Safety Update Report, Risk Management Planning, Periodic Benefit Risk Evaluation Report, Periodic Adverse Drug Experience Report, Pharmacovigilance System Master File, System Set up and implementation along with audit and training.
We will guide you to design prelaunch and post launch plan after getting new drug approval along with promotion inputs like product monograph, brochure, visual aid, newsletter and product training. We can assist you in designing artwork, patient leaflets, summary of product characteristics and product manual. You can email or WhatsApp your query. We will come back to you as soon as possible.
Cares Product Life Cycle
So that everyone can get safe medicine