All of Pfizer's data management is now outsourced, along with many other related functions such as data entry, monitoring, statistics and medical writing, said Thomas Verish, Pfizer's senior director of Development Operations, revealed at the recent Drug Information Association conference in Vienna.
"Pfizer no longer handle any data management in-house," he said.
As a result, the pharma giant has decided to streamline the outsourcing process as much as possible and moved from using a traditional mixed model - involving many contract research organisations (CROs) - to opting for a functional service provider (FSP) model - with a handful of carefully chosen niche vendors.
95 per cent of the data for its clinical trials are now managed in this way.
"We used to have 150 vendors, which was very difficult to manage.
We now have three or four doing data management, three or four doing study management and a handful of others doing related functions such as statistics and medical writing etc.," said Verish.
Under the FSP, Pfizer said it provides its chosen vendors with full time equivalent (FTE) or activity-based services for specific disciplines; the vendor provides Pfizer-dedicated resources, and typically works on several projects simultaneously; the vendor is responsible for management and training of its FTEs; and the vendor FTEs use Pfizer systems, standard operating procedures (SOPs), and processes.
"We have found that traditional project-based outsourcing, using different CROs, is problematic because they all have different standards, programmes and reporting styles," said Verish.
"With the FSP model we have them all standardise on our internal Pfizer system."
The firm no longer has any internal study-level data managers or programmers; this is all now done by the niche vendors according to specialty.
Pfizer has a handful of internal employees to manage overall timelines etc.
Through this approach, Pfizer claims it has managed to "align functionally, improve quality, and reduce cycle times."
"We are now all working together towards a common goal."
Specifically, the firm said it has been able to cut staff, decreasing transactional costs and lowering its oversight (each vendor uses its own resources and equipment within specified Pfizer requirements.)
Meanwhile, the remaining five per cent of data management is handled under a full outsourcing service model - the industry standard - where all operational and managerial aspects of a protocol are performed by the vendor.
Only very strategic and long-term trials with 5-10 year morbidity/mortality endpoints are handled in this way, said Verish.