Common CDISC Compliance Findings for Regulatory Submission

Addressing Common CDISC Compliance Findings for Regulatory Submission

The Clinical Data Interchange Standards Consortium (CDISC) recommends, and most regulatory authorities require, the use of the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards for submission of clinical study data. Since CDISC made the recommendation in 2004, pharmaceutical and biotechnology companies have been focused on complying with these standards, while also…

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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…

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A letter from Paolo Morelli. CEO

A Letter from Our CEO

Dear all, As a challenging 2020 comes to an end, I would like to thank our clients, partners, and of course employees for the privilege of working alongside you to improve the lives of patients around the world. When the COVID-19 outbreak started, we had two major concerns – the safety of our teams and…

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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 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 use…

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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…

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How to Power Clinical Trials with IoT

How to Power Clinical Trials with Internet of Things

On July 16, CROS NT’s CEO Paolo Morelli has joined a complimentary webinar organised by Avenga, global IT and digital transformation company. This exclusive webinar was prepared for Pharmatech, Life Sciences, Pharmaceutical, Drug Discovery & Development and Healthcare companies and focused on how Internet of Things (IoT) transforms clinical trials. In this blog we share…

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Webinar Q&A: Clinical trial data oversight

Webinar Q&A: Clinical Trial Data Oversight: Why and How?

Webinar Q&A: Clinical Trial Data Oversight: Why and How? On July 21, CROS NT hosted a complimentary webinar on clinical trial data oversight. During this webinar, we reviewed the components of biometrics oversight, assessed various approaches, suggested an effective data oversight strategy, and presented case studies. The webinar was conducted by: Amanda Cross – Country…

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The Approaches of Successful Sample Size Calculation

The Approaches of Successful Sample Size Calculation

In an extract from our CROS Academy course: “Understanding Study Designs & Successful Sample Size Calculation”, we discuss the different approaches to sample size calculation and why it is an important statistical component in successful clinical trial methodology and strategy. The target of drug development is to license a drug for a particular disease which…

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5-steps to effective Integrated Summaries

5 Steps to Effective Integrated Summaries

CROS NT has extensive experience in planning, managing and implementing the work required for data integration when preparing integrated summaries, both for ISS/ISE and for CTD dossier submissions. Every project is unique, and our programmers and statisticians are expert at tailoring reporting requirements in order to efficiently and effectively meet the needs of the client…

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Innovations in Clinical Trial Design

Webinar Replay: Innovations in Clinical Trial Design: Patient Enrichment Approach for Placebo Non-responders and Responders

On the 9th of April 2020 CROS NT conducted a webinar focused on the use of enrichment designs for reducing placebo response and thereby enhancing signal detection. This webinar described the use of a Sequential Parallel Comparison Design (SPCD) to increase the chance of success of clinical trials, especially trials with possibly high placebo effect.…

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International Women's Day

Leadership in the Workplace: Angela Weston

International Women’s Day takes place on March 8th and is an important day in the calendar as it celebrates the social, economic cultural and political achievements of women.  It’s theme this year is “An equal world is an enabled world”. Women today are still striving to close the gap in the workplace, and many seek out…

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PMCF studies

From the Experts: Post Market Clinical Follow-up (PMCF) Studies for Medical Devices (MDR 2017/745)

The new Medical Device Regulation (MDR 2017/745) was adopted by the European Union in 2017 and will come into effect on 26 May 2020. It replaces the existing Medical Device Directive (MDD 93/42) and introduces a number of important changes, including the strengthening of post-marketing surveillance requirements. The new regulations state that medical device manufacturers…

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Vendor Oversight

SME Clinical Vendor Oversight & Compliance Toolkit

Over the past year, there have been many buzzwords thrown around the industry: ICH GCP E6 (R2) addendum, risk-based approach, vendor oversight, data anonymization, GDPR. What makes SME clinical vendor oversight a particular challenge? Recent industry changes can be summed up into one general concept: regulatory authorities and international standards are cracking down on data…

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data collection

Are EDC Systems as Efficient as Expected? The Clinical Data Management Perspective

Traditionally, clinical research studies rely on collecting data with case report forms, which are subsequently entered into a database to create electronic records. Conventional data collection for clinical and scientific trials has focused on paper-based case report forms (CRF) followed by double data entry into a relational database. Some people are still resistant to adopt…

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ICH GCP Guideline

The Role of FSP in a Risk-Based Approach

The ICH GCP Guideline integrated Addendum provides a unified standard to facilitate the mutual acceptance of clinical data by regulatory authorities in the European Union, Japan, the United States, Canada and Switzerland. The ICH GCP E6 guideline was adopted in 1996, and clinical trials have evolved substantially in the past 21 years. The (E2) addendum…

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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…

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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)…

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Pathway to a Statistical Risk-Based Monitoring Approach

With the onset of the new ICH E6 R2 regulatory guidelines in mid-June this year, clinical trial sponsors and CROs are gearing up and tightening the framework for launching new risk-based management approaches to onsite monitoring activities. The new addendum represents the largest revision to ICH guidelines in 20 years and places all responsibility of…

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Frequent Questions about Micro Functional Service Provision

FSP – Functional Service Provision is a popular outsourcing model for clinical trial Sponsors and was originally developed by larger pharmaceutical companies to achieve significant cost reductions across a program of studies with a goal of increasing quality. This solution is not suitable for all companies due to a smaller scale project, budget restrictions or just…

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combination study

Why and When to Consider a Combination Study

Guest post by Thomas Zwingers, Head of Statistical Consultancy -Why and When to Consider a Combination Study An interesting overview on the average costs of clinical trial in different phase of drug development was given by Sertkaya in a recent article in Clinical trials 2016, Vol13(2). According to their survey, the average cost of…

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FDA guidance

Implications of FDA Guidance on Selective Safety Data Collection

The FDA recently finalized guidance on safety data collection for late-phase and post-approval trials. With this announcement, the FDA has coined the term “Selective Safety Data Collection” and aims to provide guidance on when selective safety data collection is appropriate without undermining the importance of collecting sufficient data. The FDA has specified that “selective safety…

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Micro FSP for Clinical Database Programming

Micro FSP for Clinical Database Programming: An Ideal Resourcing Solution for Small/Mid-Size Companies

Clinical database programming is a critical phase in the clinical trial process responsible for database design and build to capture CRF data. One challenge Sponsors often face is finding quality and cost-efficient resources to complete database programming tasks. With the rising costs of drug and device development (recent studies now estimate it takes approximately $2.6…

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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…

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Vaccine Trials-Challenges and Solutions

Challenges & Solutions for Conducting Vaccine Trials

The European Medicines Agency (EMA) just approved vaccine for malaria. The vaccine has been in development for 30 years and in accelerated development since 2001 and is said to have cost over $565 million USD. Conducting vaccine or biologic vaccine trials can be challenging. Vaccine trials often pose ethical questions especially since many vaccine trials are…

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The value of meta-analysis

Understanding the Value of Meta-Analysis

The combination of single trials into one meta-analysis provides a more precise and stable estimate of the treatment efficacy than analysis provided by each single trial. Evidence-based medicine is one of the most efficient ways to prove efficacy in randomized clinical trials. CROS NT discusses why meta-analysis is becoming more relevant in clinical trial data…

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The Role of Study Data in a Medical Device Market

The Role of Study Data in a Growing Medical Device Market

Medical Device trials are sometimes considered less intricate than drug development studies, however medical device studies have complexities that span across regulatory challenges, product types and unique statistical analyses and study designs. AdvaMed, an association of medical device makers, released a report saying that the medical device industry has the potential to reach $30 billion…

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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…

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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…

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How Well Do You Understand the Role of Biostatisticians in Clinical Research?

Statistics play a crucial role in clinical trials and in the drug development process – from trial design to protocol development. Having a fundamental understanding of statistical issues can uphold the integrity of a clinical trial and improve communication between clinicians and statisticians. As a clinical trial professional, non-statistician, are you familiar with the following…

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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…

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New Legislation Passed on Clinical Data Transparency – is your Company Prepared?

As of April 2014, the European Union passed legislation which will require clinical trial Sponsors to publish detailed summaries of clinical trial data in a database accessible to the public upon marketing authorization. CROS NT provides recommendations on how to prepare clinical data for greater transparency for the public and greater traceability for regulatory authorities.…

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Measuring Uncertainty in Medical Device Trials with Adaptive Designs

Biostatistics is the study of uncertainty and determining how to measure it and how to react based on the results. Medical Device trials face the following uncertainties: Safety Problems Unexpected treatment effects/safety issues High variance Effects in secondary endpoints/subpopulation Reducing uncertainty in the planning phases of device development can eventually reduce timelines, and inevitably, costs.…

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