Only 23% of 107 pharmaceutical and biotech companies rate their clinical trial management (CTM) processes as extremely effective, according to a recent AMR Research study. Another 70% believe they are under revision or, at best, slowly improving. Why? CTM processes have not yielded the scale and efficiency required to support expanding clinical trial portfolios efficiently. Since new products are the lifeblood of success, it's no surprise that CTM processes are under intense scrutiny from corporations and investors alike.

R&D groups face many CTM challenges:

1. Delivery of the right kit to the right clinic
2. Compliance with regulatory requirements
3. Decreased time to market

Our survey revealed that between now and 2010, the number of companies conducting more than 15 Phase II or Phase III clinical trials annually will increase by 40% or more. They must improve efficiency and effectiveness in CTM processes to maximize benefits from this significant investment.

Increasingly, these trials will be conducted thousands of miles away from their traditional locations. Between now and 2010, the percentage of clinical trials conducted in North America and Western Europe will drop from 55% to 38%, as more clinical trials are conducted in India, China, the Middle East, Africa, and Eastern Europe. This geographical shift will challenge already complex new product development processes, regulatory compliance requirements, and R&D organization's ability to achieve business.

These industry and market dynamics are driving the life sciences industry to rethink its CTM processes. Our survey data indicates companies are recruiting high-caliber, scientific and business talent to drive this CTM process change, and they will expect this new talent to foster collaboration to improve scale across traditional functional boundaries.

What's been your CTM outsourcing experience? Most pharmaceutical and biotech companies already outsource portions of their CTM processes. Today, data management, product return and destruction, and logistics services are frequently outsourced.

However, the companies we surveyed have not been satisfied with the results of their outsourcing experiences because their previous strategies did not deliver significant CTM benefits. Nearly half have changed their key CTM service providers at least three times in the last five years, and nearly two-thirds have changed suppliers at least twice, as they seek strategic relationships that yield measurable benefits.

In our survey, companies reported meeting schedule and budget, depth of third-party talent, and use of defined methodologies were their biggest concerns when rethinking strategic relationships with third parties. Continued rates of high supplier turnover will not provide the stability required to develop and maintain agile clinical trial supply chains. There are two key questions, two key answers:

Question No. 1--How do I get outsourcing right? R&D groups must study sourcing and supplier management techniques from other commercial industries and adopt applicable best practices as widely and rapidly as possible. Effective third-party relationships, regardless of industry, begin with the following:

1. Developing clear requirements and articulating them to potential service providers
2. Thoroughly evaluating and selecting suppliers versus established criteria
3. Engaging selected suppliers in a structured process of performance management and continuous improvement

Question No. 2--Are my internal CTM processes healthy? Companies must also evaluate their internal CTM processes to improve efficiency. Organizational structures and technical capabilities must exist to ensure the following:

1. Collaboration and integration of key activities across functional silos improve timeliness and quality of tradeoff decisions
2. Alignment of existing IT architecture supports integration of CTM activities and information flow
3. Visibility of clinical demand, all the way back to operations, reduces supply risk

The bottom line: In the future, the degree of CTM outsourcing will increase, with the focus shifting to services such as demand forecast planning. These services are more specialized than the CTM processes outsourced today, and therefore require a higher degree of talent and support from outsourcing partners. At the same time, companies must map architectures required to extend their infrastructures, business processes, and information visibility to contract manufacturers and service providers.
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