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  • Pre-Clinical Trial Data Analytics & CDISC/SEND Package Submissions

Eupraxia organization was promoted to provide technical expertise for regulatory submissions in Data Science space and to create cost-effective database solutions, modelling and analytics techniques for predictive purposes to be able to be affordable to Pharma companies, Clinical organizations, Biotech research companies, Medical Device companies, Generics manufacturers, Research Scientists/ Physicians and Academicians, Health and Hospital chain organizations and the government organizations.

Eupraxia’s talent pool has unmatched CDISC regulatory submission expertise, has managed clinical data management, bio statistics and statistical programming across therapeutic areas, across the phases of clinical trials and across the types of regulatory submissions and publication support analysis. These capabilities help our valued clients to focus on their core competencies, entrusting us to completely manage Data Science part – our core competencies. We partner with our clients by adding value to their deliverables.

The leadership team of Eupraxia has successfully managed and grown biometrics divisions of globally big pharma/CRO companies having large-scale deliveries responsibilities in the traditional CRO outfit, managed big FSP Biometrics accounts with sponsors in US, Germany, France, UK – which have no match in the Indian FSP industry. This is the reason why our clients find in us great MNC professional culture, uncompromised levels of quality and ethics, unmatched dedication to study management and deliveries, unparalleled SOP adherence and training compliance, and clear understanding and respect of clients’ biometrics team strengths.

Evolution of Eupraxia Lines of Expertise

Eupraxia takes pride in its team for it is professional, versatile, flexible and contribute to the growth of the industry.

Eupraxia has well-established itself as the authority in CDISC submission package creation and/or review of the same for BA/BE studies in India and abroad with 250+ such package submissions by mid-2020. This is achieved within less than 3 years.

Eupraxia emerged as one of three CROs in India to perform the Pre-Clinical Trial Data Analysis and SEND submission package and/or review of the same in India, Eupraxia has delivered 36+ Pre-Clinical Studies’ USFDA SEND package creations involving Single Dose Toxicity, Repeat Dose Toxicities, Safety Pharmacology (Cardiovascular pharmacology and Respiratory pharmacology) and Carcinogenicity studies. Eupraxia has 6 clients to its credit in last 2 years.

For Biotech companies, Eupraxia Modelling & Analytics team has developed predictive analysis models using biostatistics, fractals, Bayesian Network Algorithm and genetic algorithms. We have successfully delivered 5 studies in last 3 years.

In January 2020, Eupraxia acquired a medical device consulting company and built a dedicated Medical Device CRO “Alceon” around it to conduct MedDevice Clinical Trials and  MDR implementation for Europe. This strategic move was necessary to support small scale med-device manufacturers of the country to support them export their products to European markets.

Eupraxia has invested and developed tools to support statistical genetics and proteomics, using R programming language platform. Very few government-funded institutions offer these services in India but not much heard of any CRO. We have first project awarded in November 2019 in this direction.

Eupraxia has strategic alliance with Amsterdam-based health service consulting firm SparkHealth. As joint effort of this alliance, Eupraxia has developed specialization in Epidemiological Disease Modelling with first live on-going project with one of the districts of the State of Maharashtra on creating registry for COVID-19.  The computational disease modelling SBU of Eupraxia and SparkHealth provide deeper insights in to the spatial progression of the disease so as to take administrative steps by the local and state governments to minimise/arrest the adverse impact of the disease. While Eupraxia and SparkHealth provide technical expertise, Castor EDC platform company has provided its EDC platform free of charge via Eupraxia to this district administration to manage pandemic registry. Services of Eupraxia and SparkHealth for Clinical Data Management and Computational Disease Modelling are offered free.

 

Services

Clinical Data Management

As a part of data management services, EUPRAXIA’s portfolio of service

Biostatastics & Programming

As a part of Biostatistical services, EUPRAXIA’s portfolio of offering

CDISC (SDTM & ADaM)

EUPRAXIA adheres and firmly support to the principle mentioned by CDISC

CDISC (SEND)

Eupraxia takes pride in pioneering the CDISC/SEND standards in a customized way in Indian Big Pharma

Medical Affairs

EUPRAXIA offer Medical Affairs services including Development of Protocol & Attachments

Quality Assurance

Pharmaceutical industry is regulation driven and Eupraxia is committed to

Information Technology

The combination of regulatory IT compliance complexity and constant change

Case Studies

End-to-end cdisc solution

Salvaging 07 CDISC submissions

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