spacer
home > epc > summer 2018 > monitoring and managing
PUBLICATIONS
European Pharmaceutical Contractor

Monitoring and Managing

Managing clinical data is a critical aspect of running an effective clinical trial. Patient data needs to be collected according to the study protocol so that statistical analysis of the data can be conducted to prove the hypothesis of an investigational medicinal product (IMP). Effective data management is also key to helping drug companies achieve targeted costs and timelines, as the quality of the clinical data is the backbone to ensuring a successful trial that demonstrates a drug is safe and fulfils its desired effect.

Data can be managed in many ways during clinical trials, whether that be with global standardised data formats for regulatory submissions, electronic data capture platforms that are fully validated and compliant, or bespoke case report form (CRF) designs to ensure all the right data points are captured.

Data Infrastructure and Process

Establishing a robust database is key to the success of any clinical trial. The database architecture must allow all the data points required for the analysis to be collected as per the protocol, without ambiguity and in a way that can be traced back to the original source data (records at the clinical site) for each patient involved in the study.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Praveen Dass is the country head and Vice President of clinical data management for Quanticate. In his role, he is responsible for operations at the company’s office in India and is the global head of data management. Praveen has extensive leadership experience across large full-service global CROs and large multinational business process outsourcing service providers. He started his career in clinical research as a clinical data management operations manager and has since been responsible for building and managing service delivery teams across varied functional domains such as clinical data management, pharmacovigilance, and programming. Praveen also serves on the Society for Clinical Data Management Steering Committee in India.
spacer
Praveen Dass
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Teknomeks new tall cupboards elevate hygiene levels

Hygienic furniture specialist Teknomek has introduced a new range of cupboards developed with time and risk in mind. The robust units are designed to fit into SOP and reduce cleaning times, whilst eliminating trap points where dirt and contaminants could build up.
More info >>

White Papers

Inhaler Adherence: Exploring Key Factors

Aptar Pharma

Aptar Pharma recently hosted an expert panel roundtable on “Inhaler Adherence”. This international scientific forum was held in Paris, France on November 29th 2013. The roundtable was organized to explore and exchange views on the issues which may influence inhaler adherence/ compliance with a particular focus on asthma and C.O.P.D. therapies and their corresponding inhaler devices (MDIs, DPIs).
More info >>

 
Industry Events

Highly Potent Active Pharmaceutical Ingredients (HPAPI)

13-14 May 2019, Copthorne Tara Hotel, London, UK

SMi is delighted to announce its 3rd Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 13th-14th May 2019. The HPAPI global market has developed rapidly in the past year and is continuing to expand into the future, with over a quarter of drugs in development worldwide being classified as highly potent. As a result, there is a growing demand for both pharmaceutical and contracted manufacturers to adapt to the evolving HPAPI landscape.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement