Full-Time-Equivalent (FTE) enables clients to lock in dedicated staff, capacity and resources to meet GMP compliance in US & EU
Working in our GMP-compliant facilities in the US and Europe, our trained FTE scientists use our infrastructure, quality systems, validated equipment and consumables to meet our clients’ project testing needs, while integrating our operations with client quality systems and SOPs.
Throughout the 15 years we have offered the FTE service model, we have refined our FTE options to provide the most flexible approach available in the industry. Eurofins Lancaster Laboratories offers four unique choices designed to meet the testing needs of virtually any project, including:
Ideal for customers who know they have a level of work that requires a consistent, dedicated team and are looking to maintain a steady, monthly cost that is identified up front, this model is based on a minimum headcount of five, including a team leader and dedicated scientists to support a program for a minimum of one year.
Ideal for method establishment on large stability and release programs, the method establishment (validation and/or transfer) activities are performed under an FTE agreement that is based on an estimated headcount and timeframe required to complete the work. Time spent on this phase is tracked and billed on a monthly basis against a blanket purchase order that is established up front. All subsequent stability and release work, along with storage and management of samples, is conducted and billed according to the Fee-For-Service (FFS) quote.
Ideal for clients who would like a dedicated team and a monthly invoice but are unable to predict the scope of work or total resources needed, this is our most flexible FTE option. We create a core FTE team, including a designated team leader and a minimum of one scientist, and monitor the testing needs to adjust capacity as needed. Team size is variable and can flex with sufficient notice and approval.
Managed Hours FTE
Ideal for clients who are looking for the benefits of a simplified invoicing process but do not have the work flow for a dedicated team, all hours are tracked and billed monthly according to agreed-upon rates.
No matter which option is chosen, we determine the specific skill set needed for each project and assign team members based on the project’s specialized needs to ensure all areas of expertise are covered. Staff members on FTE teams work very closely together to share expertise and strengthen the testing capability within the group. We can also shift resources to accommodate changes to projects and priorities as needed.
With a history of providing FTE services for more than 15 years, 25% of our total work utilizes one of our FTE service model options.
Our program allows substitution of FTE hours to accommodate services not typically included in FTE programs, such as microbiology, raw material assays or material characterization.
We drive cost-control measures and eliminate rush surcharges for expedited testing to reduce overall project costs as well as generate customized metric reports on FTE team performance.
Through our LabAccess.comSM portal, we offer 24/7 access to raw data and reports with a timely and secure window to comprehensive laboratory information. And we offer optional integration into client IT platforms, such as LIMS.
Our FTE Programs typically support:
- Comprehensive stability and release programs for clinical and marketed products.
- Method establishment, including method development, feasibility, optimization, cGMP qualification, validation and verification of compendial methods.
- Method Remediation.
Options for Reporting and Deliverables
Eurofins Lancaster Laboratories offers flexible deliverables and tools to demonstrate how our FTE model provides value to pharmaceutical and biopharmaceutical companies, including customized reports that work with our clients’ systems. Clients can choose the metric, frequency and appearance of reports, including but not limited to:
- Hours Per Activity
- Workload vs. Headcount Metrics
- Detailed Staffing Forecast
- Monthly Utilization Reports
- Productivity Scorecard
- Turnaround Time
- Quality Metric
For more information, contact Biopharmaceutical Business Development at 717-656-2300.