OK, the decision has been made to downsize your
organization, or to remain steadfast with your core team concept, and your
company opts to select a Contract Research Organization (CRO) for your clinical
development support. And why
not? They appear to have all of the services
covered, skill and experience, and in some cases, global operations appear to be
synergized under common SOPs – I mean, you met their management and operations team during the bid defense and
their team was stellar.
So, months pass following the contract award: the scope of the project may have shifted triggering a flood of change orders from your new "partner", the contract team seems to be different from those who bid on the project - in fact, they are less experienced and skilled, and the access to senior level expertise
to guide your decision-making doesn’t appear to be as readily available as
initially promised. What happened?
In many cases, the challenge lies with both the sponsor and
CRO company when the relationship is formed. Small to medium-sized companies are being pressured to
prudently manage their resources ($), and a similarly valid argument can be
made for larger pharmaceutical companies based on current trends. The expectation of the full service CRO
is to deliver the projects on time, on budget, and of high quality – as if they
were a true extension of their sponsor partner. More often than not, there are unmet expectations and
failures to deliver due to a variety of circumstances.
Recent articles in Outsourcing-Pharma.com highlight trends
in the industry regarding large pharma/CRO relationships. One discusses that a bulk of a larger
CRO’s revenue come from larger pharma clients, while a separate article
indicates that 12 of the Top 20 pharma companies will utilize outsourcing 100% of the time. Given this dynamic,
the small to medium-sized sponsor companies offer very little in terms of backlog to
the CRO, plus create even greater challenges because of the “hand-holding”
required due to limited sponsor resource.
For the CRO, it is understandable that the larger clients get more of
the attention – the larger pharma companies have pipelines, money and keep people at the CRO
employed. This is just business.
But for the small to medium-sized client who has investor
money and personal investment in their projects at stake, time and money are of
the essence. So one wonders how
these small to medium-sized companies can be more effective in using their
selected partners, and ensure that performance, timeliness, and quality are
being maintained on their projects?
The FDA continues to increase staff in order to focus on sponsor companies and their
use of external providers, their oversight and compliance with regulations –
after all, it is the sponsor is held responsible and accountable for the conduct
of their studies.
The solutions to these scenarios reside in not only the planning stages, but throughout the life of the relationship with the CRO. Consider the following opportunities:
1. Establish a solid "blueprint" with a well-written protocol
2. Select the appropriate CRO
3. Establish well-defined Service Level and Quality Agreements
4. Include qualifications of your key contacts at the CRO company in your agreement
5. Establish an oversight team to ensure performance and quality
6. Ensure that your corporate standards are being utilized
7. Leverage technology and study reports for more effective management
These are a few simple ways to ensure that working with your
CRO partner can lead to successful clinical trials. Outsourcing of development resources continues to increase throughout the sector and, as more companies lean
towards the use of larger, established CRO companies, the more necessary it becomes to ensure that
your program receives the proper attention. In addition, it enables your core team to consider the kinds
of companies and partners that will complement your internal staff.
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