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Selection Principles

Choosing a contract research organisation (CRO) specialised in clinical R&D – particularly an international one – is not an easy process for sponsoring pharma companies. Identifying the strengths and expertise of what is a necessarily complex organisation, over a relatively quick time frame involves decrypting a maze of sophisticated processes, as well as assessing its functionality.

In some cases, CROs use promotional marketing with often blurred or simplistic phraseology, which is little help to sponsors looking for a quality R&D partnership. For example, CROs often talk about “flexibility, adaptability and responsiveness”, which enables a “better, shorter and cheaper” service. Prospective clients are left to wonder about the reality that lies behind these assertions.

We often look back in history for suitable lessons that apply to present issues. When selecting the right CRO, there is some merit in considering the military strategies of Philip II of Macedon in the 4th Century BC – a cultured and brilliant leader whose skills, planning and diplomacy brought great success. There were four underlying strategic fundamentals that Philip followed, and which today’s pharma industry can draw on when assessing potential CRO partners.

Income Statements

Without sound management, sustainable services are not possible. This was true for Philip II, and it is the same for any industry – and any CRO.

Philip annexed his kingdoms while concurrently consolidating their financial foundations – ensuring a fruitful economic development from which he benefitted afterwards. During any military expedition, his ‘bottom line’ was always positive, while he fed his ‘top of balance sheet’ through the production of gold and silver.

To transpose this to the pharma industry, the financial situation of a CRO – the essential marker of the organisation’s soundness and continuity – is the first thing that a sponsor should consider.

Two major documents should be taken into account: the yearly balance sheet, which gives an instant picture of the company’s financial status at the close of each fiscal year; and its income statement, which will highlight the enrichment or depletion of the CRO over the current fiscal year.

However, these data only become fully meaningful when considered alongside financial statements spanning at least the previous three years, or more if possible. A CRO with a healthy progression of turnover is preferred, as opposed to one with skyrocketing increases. CROs that refuse to provide prospective clients with their financial statements should be ruled out.

Contingency Management

For Philip II, the state had to be at the service of the Macedonian army and provide cash in sufficient quantity to meet the needs of scheduled military campaigns.

In clinical R&D, the budget allocated by the sponsor is to subsidise the study commissioned – and only the study commissioned – in its entirety and with all the quality required. It is therefore essential for the CRO to be able to effectively monitor the expenditures allocated to each study, so they can be audited.

A tight control of the budgeting, in particular via analytical accountancy carried out project after project, will help ensure compliance with the defined budget, and identify any concerns relating to management or financial imbalances. A CRO that has sufficient long-term assets for managing, in real time, the hazards that can occur in clinical studies can be reassuring for sponsors.

Esprit de Corps

At the Battle of Chaeronea in 338 BC, Philip II and all of the high commanding officers of the Macedonian Army were involved ‘on the ground’. This enabled them to be aware of the needs and the potential of the troops. At the same time, this involvement made the soldiers hold their leaders in high regard, helping to create an esprit de corps – boosting morale and gaining commitment of the soldiers to the army’s values and interests.

In clinical R&D, it is fundamental for a CRO to show this esprit de corps, with each participant fully responsible for himself, but also for others. This stems from a successful common experience of clinical studies and development plans, where all the departments and project teams are clearly involved.

Esprit de corps requires a management organisation called matrix structure to be able to develop under the best conditions possible. A matrix structure puts the traditional organisation per function at the service of an organisation per operation.

The organisation per function juxtaposes all of the traditional specialised departments required by clinical R&D – for example, design, regulatory affairs, clinical operations, data management, biostatistics and IT. The organisation per operation involves, first and foremost, the project leaders, whose responsibility is to ensure an optimum coordination of the various phases of the development plan.

Such a matrix structure can only work if each member of the CRO, whatever their level in the hierarchy, has optimum skills – in the same way that the Macedonian forces consisted of outstandingly trained warriors. The departments that belong to this structure per function cannot subcontract activities that belong to the CRO, otherwise all consistency is lost. Therefore, a matrix structure can only work properly in full service.

The relevance of the CRO’s matrix structure, and the competence of the development managers and the whole team, should be assessed.

Efficient Communication

Philip II of Macedon benefitted from a network of communicating staff, officers, non-commissioned officers, and recognition and liaison riders, who maintained a continuous flow of information. The high command was informed in real time of the positioning of fighting units, their condition and their opportunities. The units could then quickly receive instructions for action.

In the same way, conducting a clinical study, whatever its mode or its approach, requires the availability of efficient information in a loop system that is easy to use. The flow of information must convey, in real time and without error, all the scientific and operational data required by the authorised participants.

The IT platform itself must be a functional management tool, powerful, secured and user-friendly. It should obviously include a clinical trial management system, electronic case report forms, interactive web response service functionalities, the reporting sites and interfaces for applications. Those carrying out the study must be fully trained in its use.

From a practical point of view, it is paramount to use an IT platform elaborated jointly by the CRO’s three departments – clinical studies, biometrics and IT. Having a highly-skilled IT team within the CRO is a necessity.

Strategic Success

Given the obstacles that need to be overcome to obtain a marketing authorisation, and the exorbitant cost to pay for any mistake in the design or management of a study, sponsors cannot afford to choose an unsuitable CRO partner. Having a rigorous selection strategy will help ensure an appropriate and effective CRO collaboration and is the fi rst step towards a successful clinical study.

Whether it is a Macedonian army or a CRO, the smooth conduct of a military campaign or a clinical development plan is the result of a solid organisation – well elaborated, constructed with care and carried out by competent, skilled personnel. So turn a deaf ear to the songs of Ulysses’ mermaids promising “better, shorter and cheaper.”

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About the author

Michel Hantzperg is Chairman of ICTA Systems. He gained a Medical PhD from the University of Paris and has 10 years of experience as a medical research director in the European pharmaceutical industry. Michel launched the International Clinical Trials Association (ICTA), a full-service CRO, in 1983. In 2004, he created THEMIS, a consulting company specialised in study designs, advanced biostatistics, database exploitation and adaptive methodologies.
Michel Hantzperg
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