Working with your CRO to Conduct Efficient Respiratory Trials

CROS NT looks at the respiratory market and discusses how to efficiently conduct respiratory trials to mitigate risk and reduce costs – especially in Phases II/III trials. 15% of the world’s population suffer from a respiratory disease. Asthma and chronic pulmonary disease (COPD) are the two largest indications being researched in respiratory clinical trials. These…

[INFOGRAPHIC] EDC System Data Privacy Compliance Considerations

In the leadup to regulations on data privacy, have you considered your EDC system data privacy compliance? Why is EDC system data privacy important? Pharmaceutical companies have been anxiously preparing for the General Data Protection Regulation (GDPR) which is coming into effect this May. In addition to GDPR, there are several clinical trial regulations that…

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…

[INFOGRAPHIC] Centralized Biometrics for Small Medium Enterprises (SME)

In this infographic, CROS NT examines the benefits of the centralized biometrics outsourcing model for small to medium-sized pharma, biotech and medical device companies. Centralizing clinical data with one specialized vendor can be highly efficient and cost-effective for Sponsors when it comes to managing quality biometrics services, incorporating a technology platform and having real-time analysis…

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…

Clinical Data Transparency Programs: FDA vs EMA

In January 2018, the Food and Drug Administration launched a clinical data transparency pilot program aimed at making Clinical Study Reports (CSR) public upon approval. The pilot program begins with the recent approval of nine new drugs. The FDA is following in the European Medicines Agency (EMA) in trying to make clinical data publicly available,…

[INFOGRAPHIC] Eudravigilance and Pharmacovigilance Outsourcing (PVO)

As of November 2017, the European Medicines Agency launched a new and enhanced version of Eudravigilance. Eudravigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). CROS NT looks at some considerations for the enhanced system and…

[INFOGRAPHIC] General Data Protection Regulation (GDPR) and Health Data Challenges

GDPR will entry into force in the 25 May of 2018. CROS NT proposes an infographic about with a focus on health data. De-identification involves removing or recoding health information that could identify and individual such as patient identifiers, free text verbatim terms or references to dates. Subsequently, data anonymization involves destroying all links between the de-identified…

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 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…

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…

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)…

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…

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…

Gaining Orphan Drug Status: Complexities Removed

Orphan drug legislation and incentives have been introduced in several countries to encourage the development of treatments for rare diseases.  While the legislation brings opportunities, it also comes with numerous complex regulations and procedures.  To successfully navigate these muddy waters, it requires expertise and deep understanding of the processes and procedures involved to successfully gain…

[INFOGRAPHIC] 5 Reasons Clinical Data Visualization Matters

One of the biggest challenges of any clinical trial is sorting and managing the vast amounts of data collected. Clinical Data Visualization is the concept that data can be structured and viewed through a variety of charts and graphs to facilitate analysis. Along with data collection comes business intelligence, and Sponsors of clinical trials need…

The Human Connection: Sustainable Quality in FSP

Sustaining the quality of deliverables from FSP teams and minimizing staff turnover can be a significant challenge for Sponsors of all sizes. The contractual agreement is key for setting the correct expectations. It must be clear and specific about the level of quality expected, including measurement metrics to show performance against those quality expectations and…

5 Questions and Answers about Micro Functional Service Provision

FSP – Functional Service Provision is still a popular outsourcing model for clinical trial Sponsors. While FSP has been around a long time, several variations have emerged over the years to meet the ongoing challenges Sponsors face in drug development, including rising costs, fluctuations in workload and staff augmentation needs and finding expert resources. CROS…

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…

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…

Managing Patient-Level Data to Comply with EMA Anonymization

November 2016 is quickly approaching, and the European Medicines Agency (EMA) has set this as the deadline for complying with its guidance on clinical trial data anonymization. Data transparency has been an important issue for the EMA over the past few years and it launched a policy document in 2014 which drug development companies must…

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…

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…

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…

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…

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: 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…

EU Pharmacovigilance Legislation: Automating Signal Detection to Efficiently Manage Safety Data

In order to ensure patient safety and comply with pharmacovigilance regulations, massive amounts of safety data must be collected and analyzed. CROS NT explains how automating pharmacovigilance systems can improve the identification of adverse events with real time results. Updates on Pharmacovigilance Legislation Regulatory authorities and governing bodies have been taking steps to improve patient…

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…

Challenges & Solutions for Conducting Vaccine Trials

The European Medicines Agency (EMA) just approved the first candidate 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…

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…

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…

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…

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…

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 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…

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…

Tips for Successful Integrated Summaries (ISS/ISE) Preparation

Integrated Summaries of Safety and Efficacy are not simply study summaries, but rather they are an analysis of results that determine the safety and effectiveness of drugs in development, including rare adverse events. The ISS summarizes safety according to data generated in all clinical trials related to the product and is considered one of the…

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.…