Resource bound At a time of cost cutting, many pharmaceutical companies are bound by headcount restrictions. An outsourced team, on the
other hand, allows for the expansion of staff without an increase in headcount. This is particularly important for drug launches,
when additional studies are needed or tied to the FDA approval process.
Project Manager Checklist
Training An All-star Team
Effective training of on-site clinical teams starts with the project manager. More than anything else, the hiring of the team's
project manager is critical to the placement's success. (See "Project Manager Checklist," above.) It's necessary for pharma companies to buy in to the project manager because—once vetted—he or she plays a critical role
in building the rest of the team and evaluating what resources and levels of expertise are required to accomplish goals.
Every pharma firm has established standard operating procedures for training its personnel in all good manufacturing practices,
safety procedures, and other general facility processes. Much of this training is required by company policy or through federal
requirements. And while the pharma company must supply all the necessary pieces—test certification, training sessions, client-specific
tracking processes—the project manager and the solutions provider handle overall implementation and coordinate all training
for team members.
Other training is more job- and test-specific. One helpful technique the project manager could employ is to create a matrix
of all possible tests and each scientist's capabilities. This immediately identifies any training gaps, while highlighting
people's skill sets.
As the on-site clinical team is ramped up, it's important to manage company personnel, who may feel threatened by the outsourced
group or concerned that their roles will be the next to be outsourced. Product managers can assuage fears by interacting with
other groups and establishing a vision for the project team. Knowing that the outsourced team has a clear role within the
company and that the leader of that group can be trusted goes a long way in getting other teams to focus on their strategic
People must be managed and motivated, and by bringing in on-site clinical teams, pharma comanies can hold the hiring firm
accountable for the team performance. They can request a training matrix and use it as a checklist for completed and pending
training. They also can set a service-level agreement that guarantees all team members are certified in a particular test
by an agreed-upon date. This can include ongoing training deadlines to ensure all workers have the most current information.
The pharma company and hiring firm should discuss and agree upon the scope of the project and key performance indicators during
initial negotiations. This will allow the team's performance to be best measured throughout the engagement. While each project
is unique, there are some common key performance indicators to consider:
Turnaround time If the team operates efficiently, trials should run according to schedule. Just take stability testing: If the objective
is to verify the drug's composition within a window of time (usually two weeks), anything outside the given time frame devalues
the test because it doesn't provide accurate time-appropriate data.
OOS (out of spec) issues Setting tolerances and monitoring the team's generation of OOS issues invites the company to hold the clinical team to quality
Compliance actions All teams are subject to regular audits, whether they are internal to ensure quality assurance or external to ensure compliance
with FDA, GMP, and GLP regulations.
Staff turnover Companies with minimal staff turnover are more productive, and they reduce the time and expense of hiring and training.
Capacity levels This defines the level of work volume across the team and can determine the number of team members that are needed to meet