customer experiences of central lab services

Summary Report – December 2001

PARIOFORMA LTD 55 Princes Gate Exhibition Road London SW7 2PN United Kingdom Tel: +44 (0) 20 7225 3538 www.parioforma.com

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The objectives of this study were to:

◦ Determine Pharmaco expectations regarding the operational delivery of central laboratory services;

◦ Understand the needs of Pharmacos as they embrace e-clinical development;

◦ Understand Pharmaco requirements for international trials;

◦ Assess current and future Pharmaco needs with respect to technology trends; and

◦ Characterise the commercial relationship.

Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom

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Analysis and review of published sources of information.

Series of face-to-face and telephone interviews with senior executives with the responsibility for central laboratories within sponsor companies.

All interviews were conducted ‘blind’

The interviews on average lasted one hour, and were based on a semi-structured topic guide.

Companies were selected to represent:

◦ European and US customer perspectives;

◦ “Big Pharma to Biotech”

In total 30 interviews were conducted – covering 23 different companies


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Trends

The trend to use central laboratories in preference to local labs is now the norm for Ph II & III.

Outsourcing of laboratory services is still perceived by the majority of respondents as a low priority in the clinical development process.

Nearly all companies interviewed had “preferred partners” – usually 2 – 3 central laboratories, which were routinely used.

Preferred partner status did not confer automatic business, partners were still required to tender for business – albeit in a smaller competitive arena.

Closer relationships have been forged with preferred partners giving labs the confidence to invest in customising services.

Contracts departments are focusing on improving efficiency and cost in clinical development.

Clinical teams lack the management experience to leverage maximum potential from relationships with central labs.

The awareness of CDISC is growing, industry wide adoption of standards is still several years away. A handful of companies have incorporated CDISC standards as their global standard.


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Trends

The trend to use central laboratories in preference to local labs is now the norm for Ph II & III.

Outsourcing of laboratory services is still perceived by the majority of respondents as a low priority in the clinical development process.

Nearly all companies interviewed had “preferred partners” – usually 2 – 3 central laboratories, which were routinely used.

Preferred partner status did not confer automatic business, partners were still required to tender for business – albeit in a smaller competitive arena.

Closer relationships have been forged with preferred partners giving labs the confidence to invest in customising services.

Contracts departments are focusing on improving efficiency and cost in clinical development.

Clinical teams lack the management experience to leverage maximum potential from relationships with central labs.

The awareness of CDISC is growing, industry wide adoption of standards is still several years away. A handful of companies have incorporated CDISC standards as their global standard.


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Key Lab Features Expected

The ability to:

◦ operate to high quality standards;

◦ operate in a number of geographical locations;

◦ provide global project management services;

◦ run the tests required including any specialised tests;

◦ manage the relationship with couriers;

◦ offer short turnaround times to result reporting;

◦ create a valid and consistent database.

Project managers dedicated to setting up and coordinating logistics and kit production, site training and project initiation.

The requirements of central labs are becoming more diverse, expectations now include:

◦ e-trials and electronic data;

◦ increased customisation for customers;

◦ trial globalisation; and

◦ esoteric testing.


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Globality

Multi-centre trials are now increasingly multi-national involving investigators in various different countries on one or more continents.

A truly integrated global infrastructure is now more important than ever.

Sponsors now have a greater expectation than ever for increased support in a variety of geographical areas.

Loose affiliations with labs in other countries does not constitute a global presence.

Experience and the ability to operate in countries outside Western EU and the US is considered crucial e.g. in countries such as India, South and Central America Asia, Central and E. Europe.

The expectation that central laboratories can offer global project management (access to a global project manager) and have the operational infrastructure to support the global delivery of services.


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Protocol Design

Currently there is a low expectation for labs to be involved in protocol design.

Growing recognition by pharmacos of the competitive advantage that early lab input can have in protocol design even if it is not company policy to implement it.

It is common practice for a lab to be invited in once the draft protocol has been finalised to comment or advise on certain tests, sample transfer issues, proposed timelines, etc.

Proactive opinion upfront is highly prized, rather than labs ‘blindly’ following instructions.

Country Selection

In the majority of cases, countries are selected prior to the lab, sponsors then try to match a lab’s geographical coverage to their requirements.

Advice on how to operate in a given area or on operational difficulties in certain regions, is considered very useful.


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Project Setup and Initiation

There is a very high expectation that project setup and initiation form part of the standard service package provided by central laboratories, including:

◦ Understanding and managing all of the different needs and nuances of the investigator populations involved in a trial.

Investigator Team Management and Training

There is a high expectation that central laboratories organise and manage investigator meetings and training.

Attendance at investigator meetings is now routine and helps to reduce the work load for sponsor companies.

New web-based training packages are becoming more common, this enables site teams to access information at their convenience.


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Structure

The lines and points of communication between sponsor and laboratory change as the study progresses from contracts management to the clinical team running the project.

Although the sponsor project manager is the focal point of communication, respective heads of functions want to have active lines of communication with their counterparts in order to maintain the relationship and to handle day-to-day issues.

There is a preference that communication should be channelled through one central point (one telephone number, one email), and for this contact point to be maintained 24/7.

There is a need for access to a global project manager at the lab who has the responsibility for the coordinating the entire trial worldwide.

There is a need for open communication with a dedicated lab project manager who is really knowledgeable about the trial and who is readily accessible.


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Trends

The “vast majority” of trials are still paper based.

There was a broad consensus from all of the respondents that e-trials would become the norm in the next 2 – 3 years.

The “big pharma” respondents said that significant resources were being allocated to EDC. Some companies are taking very aggressive steps to implement EDC systems. Most companies adopting e-trials are buying/licensing proprietary software and in many cases customising it to their own needs.

The main drivers for EDC according to the respondents are:

◦ improved data accuracy;

◦ reduced time to database lock;

◦ global accessibility of data;

◦ cost savings; and

◦ trial management benefits – better monitoring of site performance and time schedules.

However, little detailed thought is being given to the integration of e-trials and lab analysis by pharmacos.


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Trends

The main drivers for data management services have been to improve the efficiency of clinical trials and to reduce the time “to database lock”.

Key changes in data management requirements that have occurred in the last 5 years are:

◦ laboratory data now provided in electronic format;

◦ improved data “combinability” with increased use of central laboratories;

◦ delivery of data according to pre-defined schedules and pre-defined standards set by the customer;

◦ laboratory data delivered to a secure web-site;

◦ the need to produce reports to assist in tracking missing visits by trial patients; and

◦ a consensus from respondents on the preference for flat ASCII files.

In the “EDC world” all systems need to be defined and developed pre-commencement of patient enrolment. Consequently, the role of the data manager in study design is likely to be enhanced and more powerful.


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Data Transfer

The majority of respondents are moving towards secure Internet-based systems driven by:

◦ the increased use of “real-time” access to lab results for trial management purposes;

◦ ease of integration of results by data managers;

◦ avoids the problem of losing diskettes in the post;

◦ reduction of the risk of double entry.

Typically, access to study data would include:

◦ daily results;

◦ cumulative results;

◦ analytical trends;

◦ patient abnormality and alert flag summaries;

◦ protocol activity reports for study management needs to track patient enrolment, visits etc.


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Pharmacos believe it is a fundamental requirement for the lab to make all the arrangements for the logistics involved in a trial as part of their project management services, including courier selection. The best service occurs when backed up by detailed Service Level Agreements.

There are widespread assumptions that labs:

◦ have a full understanding of regulatory issues regarding the logistics of sample movement in all geographical areas;

◦ that labs audit couriers on a regular basis and monitor performance and capabilities in all geographical regions;

◦ have the facility to track samples.

Evidence suggests that the above assumptions are not always met in practice.

The most difficult geographical areas for courier services include: India; Eastern Europe; South Africa; South America; Israel and China.


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Genomics

Genomics and proteomics will eventually impact on all phases of drug development; but expectations of the timescales over which this is expected to happen, varied widely.

The majority agreed that genomics is still embryonic and that a true impact is not expected much before 5 years time.

Over the next 5-10 years, pharmacos believe that labs will be responsible for pharmacogenomic and pharmacoproteomic test development and validation; and the high-throughput genotyping of subjects in clinical trials. The exact format that these tests will take is still unclear.

However, it is clear that the impact of this new technology will manifest itself by creating a massive increase in the raw data being fed into the development process and into clinical trials.


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Price although important in selecting a laboratory, was rarely given as the main decider. It is always a factor in the decision process, but never at the expense of quality.

High prices are not necessarily linked to high quality differentiated services.

The lack of transparency in pricing structure offered by central laboratories continues to be an issue – customers desire prices to be “unbundled.”

Contract managers want to understand what they are paying for, and how the money will be allocated – i.e. what is included and excluded in the tender price.

Completion of price templates to facilitate comparisons, is one approach being tried by sponsors.

Respondents reported wide variations in the tender prices for studies.

Respondents in general found it difficult to articulate what they expected in terms of “value.”

Value-added services are not about adopting “new fashions,” or “new fads,” or even adding new services to offerings that are only perceived to increase costs; but services that can demonstrably improve the business processes of the sponsor.


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Sponsors have a preference for one laboratory to handle everything:

◦ to reduce the complexity of the supply chain;

◦ to ease contractual management;

◦ to satisfy the need for continuity on an individual candidate basis.

The benefits of continuity:

◦ time savings – lab already knows working processes;

◦ cost savings – lab does not have to reconfigure work processes to meet customer’s needs;

◦ avoidance of repetition and of rework; because

◦ the lab understands the expectations of the study team.

Key issues raised by sponsors in developing and maintaining relationships:

◦ divergent business aims – lab focus on last project dollar, no incentive to think long term;

◦ poorly defined communication structures;

◦ inflexible to customer needs both pre-project and during project;

◦ opaque in commercial negotiations;

◦ inconsistent service delivery – particularly for smaller projects.


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Consequently relationships are “arms length” and “transactional.” “Preferred partners,” are in essence only “pre-qualified” and are not “strategic.”

Sponsors are not yet configured to deal with strategic partners and are wary of long-term work commitments to labs.

Sponsors want:

◦ to leverage lab expertise;

◦ labs to become an “extension” of their clinical teams; and

◦ to establish a more “participative” style of relationship.

This necessitates a higher level of trust so that labs would be comfortable in:

◦ being highly proactive;

◦ constructively critiquing protocols;

◦ challenging sponsor thinking;

◦ identifying cost savings for the client; and

◦ becoming strategically aligned in terms of culture, approach and ambitions.


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customer experiences of central lab services

Health & Medicine

central laboratories

princes gate london

requirements of central

pn united kingdom

preferred partners

different companies

local labs

eclinical development