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ICHGCP E6 Addendum R2 - What do you need to know?

Gavin Boodoo



The ICH Guidelines for Good Clinical Practice (E6) has morphed into the international standard for clinical trial conduct since its inception twenty years ago. However, within that period, clinical research has changed dramatically and it is a credit to it’s authors that ICHGCP remains relevant today, with only one previous notable update seen in response to electronic data capture (EDC) technologies being widely utilized by the industry. 

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Topics: Good Clinical Practice (GCP), FDA, Remote Monitoring, Quality Assurance, Data Transparency, Additional Monitoring, Technology Trends, Risk Based Monitoring, Centralized Monitoring, ICHGCP E6

The Cost Considerations of Outsourcing to a Clinical Research Organization

Commercial Team

Outsourcing as a business practice has been around for centuries and some economists would argue it has been around since man first started providing services to one another. The concept is based on the premise that a specialist company that focuses on a specific functional area can do a better job faster, and at less cost, than a generalist approach whereby you employ all functional areas needed internally. The practice has become entrenched in many areas of industry including the Pharmaceutical and Biotech industry and has fuelled a boom in companies carrying the acronym CRO (Clinical Research Organization).

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Topics: CRO Selection, Outsourcing Solutions, Strategic Resourcing, CRO Project, CRO Efficiency, Clinical Research Organization, Offshore Locations, Clinical Data Services, Functional Outsourcing

Making Metric Collection Obligatory in Clinical Trial Contracts

Medical Writing Team

Establishing robust metrics at the start of a study, and systems to monitor them in an ongoing manner, should be integral to all work that a Clinical Research Organisation (CRO) performs. There is an expectation from clients that metrics will be used to monitor progress or lack of progress, including deviations from the planned schedule. However, these metrics are sometimes not defined clearly at the outset and often not incorporated into clinical trial contracts. A lot of metrics need to be “balanced” between what is controllable by the CRO and what is controllable by the sponsor. Therefore, the metrics that are incorporated into a contract need to be carefully chosen. Ideally it should be a small and accurate set of performance metrics that will meet the customer’s needs and enforce efficient information flow – it being a breach of contract not to provide and review the metrics.

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Topics: Metric Collection, Clinical Trial Contracts, Clinical Trials, CRO Project, CRO Efficiency, Project Management

Should We Be Integrating Mobile Health Apps in Clinical Trials?

Statistical Consultancy Team

Wearables and mobile health (Mhealth) apps collect subject/patient data from mobile or purpose built devices to record data in real time. The rationale behind this type of technology is to reduce the burden on subjects by eliminating unnecessary procedures, streamlining routine procedures and reducing time spent at clinical trial sites. It is evident from the review of a range of literature that studies integrating some form of mobile health technology can be broadly categorised into a few phases of development: studies on the development of new devices, studies on the validity of functional wearable devices, studies comparing new device and conventional endpoints, and finally those studies which trial the device as a health intervention. This article aims to briefly discuss these phases with reference to examples of recent studies demonstrating some safety or efficacy endpoint relating to a newly developed device.

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Topics: Clinical Trials, Clinical Study Design, Biostatistics Consulting, Technology Trends, Wearables in Clinical Trials, Wearables, mHealth

A Review of the Annual PhUSE 2016 Conference

Clinical Programming Team

A number of team members were able to represent Quanticate at the PhUSE 2016 annual conference in Barcelona. The PhUSE annual conference is an opportunity for programmers and statisticians to both learn from and share cutting edge knowledge with the pharmaceutical industry. This year, Quanticate presented on producing high quality SAS graphics using the advanced Graphical Template Language (GTL) to bring individual plots together to aid analysis without sacrificing any aesthetical properties in the process. Conference attendees were spoilt for choice with approximately 5 simultaneous presentations every half-hour across 15 streams in total. Here are some interesting presentations which the team enjoyed over the conference duration.

 

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Topics: Programming R, Clinical Programming, SAS Programming, Visualization, Conferences, SAS Graph

The Evolution of Risk Based & Remote Monitoring

Gavin Boodoo

With a growing trend towards the use of risk based monitoring, and with new technologies available to support this alternative to traditional onsite monitoring, there remains inertia to implement this approach. Having discussed remote monitoring capabilities with industry peers, we have identified the root cause of this reluctance as an intrinsic fear of flouting regulatory compliance within the conduct of a clinical trial.

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Topics: Regulatory Requirements, Clinical Trials, FDA, Remote Monitoring, Remote Data Capture, Source Data Verification (SDV), On-Site Monitoring, Risk Based Monitoring, Centralized Monitoring

A Guide to the Benefits of Centralized Clinical Data

Commercial Team

If a pharmaceutical, biotech or medical device company outsources its clinical trials, it may be neither practical nor advisable to use one single Clinical Research Organization (CRO). Smaller CROs may not have the infrastructure to deliver large multinational trials, and large CROs may not offer the level of attention or flexibility required for smaller, but no less important, clinical studies. However, whilst the choice of CRO may be study dependent for the clinical aspects (such as patient recruitment, monitoring, clinical project management and regulatory expertise) there are tangible advantages to centralizing all data handling activities with a single provider – one that supports clinical data management, biostatistics, pharmacovigilance and medical writing services.

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Topics: Clinical Trials, CRO Selection, Clinical Data Storage, Centralization, CRO Project, CRO Efficiency, Clinical Data Services, Functional Outsourcing

How Well Written Proposals Affect Clinical Research Organization Selection

Commercial Team

Selecting the right Clinical Research Organization (CRO) is vital to the success of any clinical study. Get it right and the months that follow will be that much more enjoyable because the study is more likely to run smoothly and stay within budget. Those sponsors who have had to transition a clinical study away from a poorly performing CRO to an alternative supplier, mid-study, will be acutely aware of the pain that this can cause and the need for a thorough vendor selection process. The Request For Proposal (RFP) is a vital component of that process. A well-defined and comprehensive RFP creates the best chance of selecting the most appropriate CRO, or combination of CROs, to complete the project.

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Topics: CRO Selection, Centralization, CRO Project, CRO Efficiency, Clinical Research Organization, Clinical Data Services, Request For Proposals

Integrated Summaries of Safety & Efficacy for Regulatory Submissions

Statistical Consultancy Team

Far from being simply a summary of individual results, a comprehensive and detailed summary allows companies to make informed decisions. Producing comprehensive integrated summaries of safety and efficacy is a critical stage of the submission life cycle. These need to be designed and planned carefully in advance to ensure informed decision-making and effectiveness at the regulatory interface. A focus on the approval and whole lifecycle of the product, and not just the submission, will influence the quality and direction of the content. Traceability is key in all respects of the creation of information, from data that leads to knowledgeable decisions and the ultimate wisdom that forms the label of a product.

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Topics: Regulatory Requirements, ISS/ISE, FDA, Integrated Summaries, Medical Writing, Biostatistics Consulting, Phase 3 Studies, Phase 2 Studies, Statistics

Creating High Quality Graphics in Clinical SAS Programming

Statistical Consultancy Team

Utilizing the newer SAS graphical procedures such as SGPLOT and SGPANEL rather than the original SAS Graph procedures is becoming more and more popular in statistical programming through their many user friendly utilities, such as overlaying multiple graphics and adding reference lines with ease. However, as with its predecessor, SAS Graph, any requirement for restructure of the graphical elements still proves to be relatively rigid when sticking to these core graphical procedures. This usually results in creating bespoke program code for each figure which undoubtedly takes time and also runs the risk of inconsistencies across figures.

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Topics: Clinical Programming, SAS Programming, SAS Graph, PROC Template

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