CROS NT Joins PHUSE Eu 2021

PHUSE EU Connect 2021

We are pleased to announce that this year we will be joining PHUSE EU Connect 2021 as delegates and sponsors of the hands-on workshop “Clinical Trial Safety Analyses – Common Pitfalls and FAQ” conducted by Eli Lilly.  Event information: Event format: Hybrid Date: 15 – 19 November 2021 Registration & agenda: available on the official website…

Clinical Data Oversight Webinar

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…

Micro-FSP

Micro-FSP for Small Pharmaceutical Company

Background CROS NT is currently providing an operational and a consulting team to a small pharma that specialises in rare diseases. Our client was setting up a new department that required a flexible resourcing solution for data management, biostatistics and statistical programming to supplement their existing small team. We assembled a team that is highly…

Webinar Q&A: Clinical trial data oversight

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 Manager US and Executive Director of Service Strategies, CROS…

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…

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…

FSP

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…

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

The Cost of a Failed Clinical Data Strategy

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 -…

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…

Vaccine Trials-Challenges and Solutions

Challenges & Solutions for Conducting Vaccine Trials

In 2015, the European Medicines Agency (EMA) 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…

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…