EDC Design

EDC Design with the End User in Mind

User experience is important within any software as it focuses on ensuring the product is doing its job correctly and in the most helpful way.  An EDC system designed with the end user in mind streamlines data capture for all clinical trials and leaves a favourable impression. A poor user experience, on the contrary, tends…

medical_coding_data_management

Medical Coding in Data Management: Manual vs Auto-Coding

Medical coding is an important step in data cleaning activities within data management. The main objective of performing medical coding is to have the medical terms interpreted uniformly and in a standardized format; hence medical coding is required to be completed by using standardized medical dictionaries. In CROS NT coding is usually performed within the…

Clinical Data Management System

Implementing a new Clinical Data Management System / Electronic Data Capture Tool: the Challenges

Drug Development is a very competitive global environment and there is considerable pressure on most organisations to make their operational processes more efficient and effective. Pharmaceutical companies, biotechs and CROs are asking for innovative tools that are cost-effective, intuitive, easy-to-use and compliant to regulatory requirements. The implementation of a new Clinical Data Management System (CDMS)…

CRF_Design_Oncology_ Studies

Ask the Experts: CRF Design Considerations for Oncology Studies

As most clinical trial professionals know, oncology is a unique therapeutic area that deals with the prevention, diagnosis and treatment of cancers. Oncology studies usually require more lengthy and intricate CRFs due to the nature of the therapeutic area, the nature of the tests and examinations performed and the type of data collected and required…

Analyzing_data

Data Fraud in Clinical Trials: Types of Fraud & Detection

With the rise of Risk-Based Monitoring as an efficient and cost-effective clinical data strategy, regulatory authorities and clinical trial sponsors have raised concerns over data fraud. The FDA, for example, reviews and audits several clinical trial sites for “fraud, incompetence and misconduct”. When it comes to clinical data, a clinical trial database can never be…

Businesswoman works with eclinical solutions

Strategic Clinical Data Outsourcing: Cloud-Based eClinical Solutions

When it comes to clinical data outsourcing, Sponsors rely on several factors to select and qualify vendors. The most prevalent outsourcing method remains the use of full-service CROs, but there is a growing trend to outsource based on CRO specialization including biometrics services and technology offerings. The centralized clinical data approach keeps all clinical data…

global clinical data

5 Things to Consider in a Global Data Strategy

Most clinical trials today are being conducted on a global level with vast amounts of clinical data to collect, analyze and report. Trial strategies include collecting clinical data from multiple sources and sites, ideally in real time so Data Managers can manage discrepancies and unusual data patterns and Biostatisticians can analyze incoming clinical data and…

Why Consider Cloud-Based EDC for Your Next Clinical Study?

The eClinical trial technologies market is set to reach $1.37 billion USD by 2018. The driving forces behind this surge are the need to optimize the drug development process through real‐time data analysis and while cutting costs along the way. While various sectors such as small and large pharmaceutical companies, biotechnology companies and medical device…

Strategies for Reducing Clinical Data Management Costs Without Sacrificing Quality

Clinical Data Management has certainly evolved over the years to reflect the changing clinical trials landscape. Pharmaceutical, biotechnology and medical device companies rely on various outsourcing methods to carry out data management activities such as putting a Functional Service Provider (FSP) team in place for product-specific work, outsourcing to low-cost countries or centralizing biometrics to…