Clinical Data Oversight Webinar

Webinar Highlights: Clinical Trial Data Oversight: Why and How?

Why is Clinical Data Oversight Important? Oversight is a requirement of the ICH E6(R2) addendum, according to which the ultimate responsibility for the quality and integrity of the trial data resides with the sponsor. What is more, this addendum also requires a risk-based approach to quality management and oversight. Conducting clinical data oversight in compliance…

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…

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…

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…

Data Oversight

Webinar Replay: Clinical Trial Data Oversight: Why and How?

On the 21st of July 2020 CROS NT conducted a webinar focused on clinical trial data oversight. During the webinar titled “Clinical Trial Data Oversight: Why and How?”, we reviewed oversight as it relates to data collection and reporting, analysed options for oversight including an assessment of different approaches, discussed the benefits of a centralized…

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…

Webinar highlights: Dual roles: I am not just a programmer

Webinar Highlights: Dual Roles: I am not just a programmer!

The most satisfied and hard-working employees are those who feel challenged and supported in their professional development. Employees at CROS NT can work in dual roles, not only in management but also in operational areas. This gives experienced employees the opportunity to move into roles with more leadership potential or which demand higher-level or different…

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…

Programmer

Webinar Replay: SPO1: Dual Roles. I’m not just a programmer!

On the 31st of March 2020 CROS NT conducted a webinar focused on the ways statistical programmers can work in dual roles and expand their skill set, as well as support different operational groups and get involved in the upfront project planning. Webinar learning outcomes: Importance of retaining employees through professional development How statistical programmers…

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.…

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…

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…

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…

integrated summaries

How to Keep Integrated Summaries (ISS/ISE) Projects Under Control

Costs associated with integrated summaries of efficacy and safety (ISS/ISE) can be burdensome for some Sponsor budgets – with increases arising from all sorts of factors from consistency issues to meeting tight timelines. How can these costs be reduced and timelines maintained? Gap Analysis The key to faster and more efficient preparation of ISS/ISE lies…

Risk_Based_Monitoring_Implementation

Implementing Risk-Based Monitoring from a Data Perspective

Each sponsor and their partners enter the Risk-Based Monitoring (RBM) process at different places. Now that the new version of GCP (ICH GCP E6 (R2) addendum) mandates risk-based thinking, all of us in clinical trials need to embrace risk-based processes. What exactly does this mean? We need to begin implementing risk assessment, risk measurements, task…

hands_holding_medical_tools

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…

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…

MCP-Mod approach

The MCP-Mod Procedure for Dose-Response Testing and Estimation

Summary: The MCP-Mod approach affects both the design and the analysis of dose-finding studies. It is a hybrid approach that combines hypothesis testing and modeling to analyze phase II dose-ranging studies with the purpose of finding suitable dose(s) for confirmatory phase III trials. The MCP-Mod method was found adequate and appropriate for dose selection based…

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)…

expertise analyzing data

Accessible Expertise for Large Pharma to Virtual Biotech

No matter the size of the organization – from large pharma to virtual biotech – it’s critical to know that you have immediate access to expertise from your CRO.  Large pharma’s need for expertise tends to be very specific, including an occasional need to bring in outside assistance if its own staff is overburdened.  Conversely…

Risk_Based_Monitoring_Centralized_Statistical

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…

Functional_Service_Provision_Clinical_Trials

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…

medical writer

The Role of the Medical Writer in Regulatory Submissions

The current climate for drug and device development promotes an ever increasing need for companies to launch new products onto the global market as quickly as possible. The medical writer performs a key role in facilitating this process. A medical writer who understands the process of drug or device development and regulatory strategy is an…

Structural Equation Modeling

The Case for Structural Equation Modeling in Clinical Trials

In this week’s blog, the CROS NT Biostatistics Methodology team presents a description of how Structural Equation Modeling (SEM) can be used in clinical trials. Structural Equation Modeling is a set of mathematical models and statistical methods used today in biostatistics. However, its use in clinical trials has not been widely accepted yet. CROS NT…

statistical_methodology _clinical_team

The Value of Basic Statistical Training for Clinical Teams

In the complex world of drug development, the interaction between the various stakeholders is essential for the success of a project. A fundamental part of communication is a basic understanding of the problems, terminology and way of thinking of your team members and partners. Traditionally, statisticians have a particular way of thinking, which is very…

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…

combination_studies_clinical_trials

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 et.al. in a recent article in Clinical trials 2016, Vol13(2). According to their survey, the average cost of…

Medicine_doctor_hands_holding_capsule_medicine

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…

clinical_data_analysis

The Cost of a Failed Clinical Data Strategy and How to Avoid it

How can Sponsors plan effectively in the trial design and clinical data strategy phase? Drug and device development is a grueling process with long timelines and excruciating costs. Throughout the trial process, Sponsors often face obstacles that delay timelines and inevitably increase costs. Even more frustrating, the odds of success are stacked against Sponsors –…

clinical_database_programming_resource

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…

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…

clinic_research_work

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…

accelereted pathway medical devices

Getting Med Tech to Market Faster: FDA Approves Accelerated Pathway

Last week, the FDA announced that it approved an accelerated review process and pathway for critical medical devices. The goal behind this effort is to get medical devices to market faster, particularly devices “that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions”. The accelerated pathway gives these…

drug_trials

The Cost-Benefit Analysis of a Centralized Data Outsourcing Model

To further demonstrate the benefits of a centralized data outsourcing model, CROS NT discusses a cost-benefit analysis of choosing one vendor for all clinical data services. The benefits of a centralized approach include standardized data formats, improved traceability, greater leverage of work from one study to the next and significant cost reduction. The benefits of…

medical tool

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…

Avoiding High Charges from CROs for Integrated Summaries

Integrated Summaries (ISS/ISE) are often required by health authorities when submitting a new drug application. It is important to note that integrated summaries are not simply study summaries, but rather they are an analysis of results that determine the safety and effectiveness of drugs in development. ISS and ISE are also an integral part of…

Medical report and stethoscope lying over x-ray

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…

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…

Good Practice Designs: Biostatistics for Breast Cancer Trials

October is Breast Cancer Awareness Month, and CROS NT is addressing the implications of conducting clinical studies in breast cancer and how Sponsors can implement smart designs and strategies to conduct more efficient trials. Oncology is perhaps the most complex therapeutic area in clinical trials with over 450 indications and various unique characteristics like slow…

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…

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…

The Advantages and Disadvantages of Endpoints in Oncology Trials

In this week’s blog post, we look at an extract from an article written by CROS NT’s expert biostatistician, Thomas Zwingers, on adaptive trial design for oncology studies. How can biostatisticians use adaptive trial designs to deal with the advantages and disadvantages of endpoints in oncology studies? Oncology is significantly different than other therapeutic areas.…

Analysis Considerations for Integrated Summaries of Safety & Efficacy

Statisticians and statistical programmers are crucial team members in planning, producing and presenting integrated summaries. Planning well in advance for ISS/ISE is the first step in saving time and money. Statisticians will need to outline the specific issues that the integrated summary will need to cover and should attend pre-submission meetings with regulatory authorities to…

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.…