How to Build a Clinical Trial Data Strategy

How to Build a Clinical Trial Data Strategy

Data Strategy – What Is It? You can consider a data strategy as a road map guiding you on how you will collect, manage, store, and report your clinical trial data. The best, most comprehensive strategies define, at a minimum: How you will collect and clean your data Any therapeutic area-specific data needs A data…

Defining Clinical Trial Data Strategy

Defining a Clinical Trial Data Strategy: How to Effectively Manage Your Key Asset

Outsourcing your biometrics separately from your clinical services brings increased data quality and access, shorter timelines, and reduced costs. Implementing an overall clinical trial data strategy and data standards will maximise these savings. At Outsourcing for Clinical Trials Europe 2021, we presented the best practices for defining an effective and efficient clinical trial data strategy.…

White Paper: Unlocking the Database Lock Process

White Paper: Unlocking the Database Lock Process

Key Factors and Practical Advice for Database Lock Success About this white paper Clinical trial database lock is an extremely collaborative process and can be overwhelming, stressful, or inefficient. However, a close collaboration between the Project Manager, the Clinical Monitoring Team, and the Data Management Team can minimize the time to database lock.  In this white paper by CROS NT and Alira Health, you will find best practices for conducting a smooth database lock that produces complete and accurate data and minimizes the time to study results.  Do you have any questions about database lock process? Contact us!  Download the…

Your favourite blog posts 2020 on Life Sciences trends

Your Favourite Blog Posts from 2020

In 2020, we worked hard to keep you updated on main trends of Life Sciences world. We covered a whole range of topics from risk and mitigation during COVID-19 pandemic to clinical trial design in small populations and building a robust EDC system. You can find the full list of our expert articles in the…

Best practices building a robust EDC system

Five Best Practices for Building a Robust EDC System

Electronic data capture (EDC) systems are essential and ubiquitous tools used in the Life Sciences industry by the academic, medical device, biotech, and pharmaceutical companies. A robust EDC system can help you to: Streamline eCRF development process; Minimize the disruption in the case of the mid-study changes such as a protocol amendment; Maximize ease of…

EDC Design with the End User in Mind

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

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)…

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…

Data Fraud in Clinical Trials

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…

Cloud-Based 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…

Things to Consider in a Global Data Strategy

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? Cloud-Based EDC for Your Next Clinical Study?

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…

RBM: Centralized Statistical Monitoring & Technology Considerations

RBM: Centralized Statistical Monitoring & Technology Considerations

Risk-based Monitoring (RBM) of clinical trials is an approach that combines on-site monitoring along with centralized remote monitoring by coordinating centers. Based on risk assessments about how the clinical information is captured and protocol designed, risk-based monitoring activities can be proactively supported by the usage of reporting tools. CROS NT discusses the considerations and impact…

How reducing clinical data management costs without sacrificing quality

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…