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Publications by Adamas Consulting Staff

Abstracts from the following articles can be viewed here:

Effective Outsourcing - Avoiding the Pitfalls - Itsuko Maeda
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Outsourcing of clinical trial-related activities has become complex and expensive, and as such an effective outsourcing process is crucial to obtaining results with an acceptable quality in a timely manner. A strategic approach to outsourcing, team assessment of CROs and well-prepared contracts can avoid many potential problems. A balanced and active management of CROs, good communications, and working with them as partners are keys to success. This article will discuss some of the tips for Japanese sponsors to avoid the pitfalls associated with outsourcing clinical activities from a QA auditor's perspective, with focusing on outsourcing to CROs outside of Japan.
Full article in Japanese pdf can be read here.

Abstract from the full article in Bulletin of JSQA, Number 6 p209-214 (July 2004).


What Every CRA Should Know About GMP (and was afraid to ask) - Stephanie Hill
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Even though the deadline for implementation has passed, there is still much confusion among clinical research professionals about how the European Clinical Trials Directive 2001/20/EC (CTD) will affect the way in which we work. Despite the numerous guidance and discussion documents that exist and the training courses and seminars that have taken place, I have yet to meet a person who feels that they are fully prepared for the changes that will be enforced on 1st May 2004.
Full article as a pdf can be read here.

Opening paragraph from the article in GCPj, Vol 11 Issue 7 p27-29 (July 2004).


Joining the Dark Side, from CRA to QA - Stephanie Hill
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I doubt that many people would argue that the role of the Clinical Research Associate (CRA) is vital to the success of any clinical trial. This is not only because this job provides a direct link between the sponsor and investigator but also because the CRA is the last guardian of quality, ensuring that the site staff are well informed, provided with the necessary study materials and able to resolve site level issues or decide when further action is required.
Full article as a pdf can be read here.

Opening paragraph from the article in CRFocus, Vol 15 Issue 6 p27-29 (July 2004).


The Impact of Directive 2001/20/EC on Clinical Trials - Patricia Fitzgerald
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Directive 2001/20/EC was published in the Official Journal of the European Communities on the 1 May 2001. The contents of the Directive must be transposed into the national law of each Member State by May 2003 and must be implemented by May 2004. Member states may implement the Directive before the due date.
The Directive applies to all clinical studies and all phases of clinical development including bioavailability and bioequivalence studies, no distinction is made between commercial/non-commercial studies. The Directive does not apply to noninterventional trials.
This article explores the impact of the Directive on the conduct of clinical trials in Europe.

Abstract from the full article in Global Outsourcing Review Winter 2003; Vol 5 No.4 p84-86


GCP Auditing Methods and Experiences By an Expert Group of the German Society of Good Research Practice (DGGF) - reviewed by Patricia Fitzgerald
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FOR anyone who wants a comprehensive overview of the clinical auditing process this book is invaluable. It is clearly and logically written with plenty of useful advice provided by some of the most experienced clinical auditors in the industry.
The first chapter sets the tone when it describes quality assurance (QA) as 'an integral part of product development' and 'one element of a quality management system'. The second chapter on the audit schedule expands this theme with advice on drawing up a strategic QA programme for each development project managed by a 'project auditor'.
Given the limited resources in most QA departments and the increasing complexity of clinical studies, moving away from study- to a project-level auditing would maximise the use of resources and have a more significant impact on continuous quality improvements.
Several chapters adopt this more 'modern' strategic approach to clinical auditing. For example, the chapter on investigator site audits approaches them as part of a 'systematic verification of the different activities in the overall processing of a clinical study'. This enables auditors to see the bigger picture and assess the impact of audit findings across all investigator sites in the study, not just those that have been audited. As the book states, this strategic approach is neither understood nor adopted by many companies.
Although most chapters give detailed information on the conduct of different types of audits, some useful points were overlooked, such as sample selection criteria and sample size. The chapter on data management, statistics and medical writing was notably good, however. The authors provided some very useful and practical information on sampling data for these types of audits.
The two chapters on validating computer systems in clinical trials, and the specific aspects of validation in studies performed with the aid of an electronic data capture system, were disappointing in that they did not provide a good understanding of how to audit such computerised systems. Notably neither chapter stated the need to train all staff involved in any validation activities and GCP aspects, and they placed too much emphasis on the validation activities of the end-user rather than the validation activities required across the full software/system development lifecycle.
On the whole, I found the book easy to read and informative. It will be of interest not only to clinical auditors, but also to those being audited to enhance their understanding of the process.

Title published by Editio Cantor Verlag, Germany, 2003 ISBN 3-87193-284-1 Price E58 (www.ecv.de). This book review appeared in Good Clinical Practice Journal Vol 10 No 12 Dec 2003 p27


Outsourcing - Avoiding the Pitfalls - Sherif Odaranile
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Outsourcing of clinical activities has become a complex and expensive business with inherent risks that could, if continued in a haphazard manner, lead to the squandering of resources, both in terms of money, time to registration of a product and personnel time. There are many crucial elements that must be present to ensure a successful delivery of a project on time, on budget and to an acceptable quality e.g. a strong relationship between the partnering parties, effective and relentless communication, and a clear understanding of what is required in terms of project specifications and responsibilities. This article will look at some of the issues associated with outsourcing clinical services and suggest ways to avoid the pitfalls.

Abstract from the full article in Global Outsourcing Review 2002; Vol 4 No.3


CRO Selection - A Process Re-visited -Sherif Odaranile
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The tactical and isolationist nature of the approaches by pharmaceutical companies toward clinical outsourcing may reduce the value that they derive from the process. This article aims to look at the core processes involved in the selection of a CRO partner whether a Sponsor decides to approach the process in a tactical or a strategic manner. The article will describe and suggest how best to structure the Sponsor's outsourcing teams to maximise the returns on investment. There should be a focus on Quality in the selection process. Quality will then dictate the acceptable price. The current focus is on price which has produced variable quality in terms of contractual delivery and regulatory acceptability.

Abstract from the full article in Global Outsourcing Review 2002; Vol 4 No.3


The Clinical Auditor- Patricia Fitzgerald
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The skills required of a Clinical Quality Assurance (CQA) Auditor are similar to those required for a Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP) auditor, with perhaps more emphasis on interpersonal skills and a requirement for more international travel. However, the role of the CQA Auditor and the Good Clinical Practice function is still evolving. In general, the tasks required of the CQA Auditor involve the reviewing and compliance verification of quality systems throughout the clinical development process, from the design of the protocol to the final clinical study report.

Abstract from the full article in Quality Assurance Journal 2000; 4, 79-82


Strategic Clinical Quality Assurance - Patricia Fitzgerald
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It is very concerning that quality in clinical trials, as measured by quantitative trend analysis does not appear to be improving even though clinical quality assurance functions have been actively auditing trials in the US and Europe for several years. Could one reason for this be that CQA are directing their efforts at individual, usually pivotal, studies and not looking at the ‘big picture’ i.e. clinical development as a whole? Barnett et al2 conducted a poll of CQA units and their activities in 1995 and found that 55.7% of audit time was spent on auditing investigator sites. Therefore, a great deal of time, money and effort is being focused on making small quality improvements to individual investigator sites for a selection of studies.

The companies that maximise the potential of CQA functions and include quality as an integral part of the clinical development strategy, are likely to see faster and more permanent improvements in quality with efficiency improvements, and subsequent reductions in time and cost, for all R & D programmes.

Abstract from the full article in World Markets Business Briefing: Pharmatech – An Analysis of the Pharmaceutical Industry and Perspectives on the Future (April 1999), CD Rom Technology Section.

 

Difficulties Encountered in the Validation of Computerised Systems -Enrique Rafalin
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Computerised systems are becoming ubiquitous in today's pharmaceutical and CRO industries. Regulatory requirements and guidance documents exist to guide users, but an accurate portrait of the major problems and the true commitment required to achieve and maintain computer system validation has been under emphasised in the pharmaceutical press. Electronic systems' promises of shorter development times, lower error rates, greater control and flexibility, reduced costs and increased profits should not blind users to the potential pitfalls and the real requirements in terms of staff, time and resources that validation requires. The lack of sufficient high level planning required to achieve validation is a common theme unifying many of the issues that frequently lead to validation problems. Management buy-in and support of validation activities should come from the top, both in terms of leadership and resourcing. It is crucial to include validation as part of the overall project scheduling and to identify from the outset of any project all the risks to the validity of the target system and all related systems. Additionally, the mulit-disciplinary/multi-departmental nature of CSV projects should not be overlooked. The benefits of computer validation go beyond compliance with regulations. Proper validation makes good business sense "by ensuring quality, timeliness and efficiency, and by addressing business risks."

Abstract from the full article in Business Briefing Pharmatech (2000)

“I appreciate both of you again for your excellent audit and teaching me a lot about CRO audit, GCP and related regulations etc.”
O.O., Director Regulatory Auditing, Japanese Pharma