Customized Functional Services.

Core Competencies.

Our custom-designed Biometrics Services target the areas of:

  • Biostatistics
  • SAS Programming
  • Clinical Data Management

 

Services Offered.

CSG carefully calibrates a delivery framework for the unique challenges and objectives of every customer environment.  Our approach is highly collaborative so that our customers’ perspective is clearly represented in the final solution and they maintain confidence the partnership is designed for their specific needs, no more and no less. A solution can contain any combination of our six core areas of expertise.

Plan Validation

Our Plan Validation offering is a consultative service. Using our extensive Biometrics experience in the industry, we can review a customer’s project-specific documents and provide input and validation of those plans.

Plan Validation

We review and assess:

  • Protocols; Statistical Analysis Plan (SAP); and Table, Figure, and Listing (TFL) shells.
  • Team size and composition is appropriate to complete the work.
  • Proposed timelines are reasonable

Team Curation

Team Curation is all about crafting a specific team for each customer engagement. With CSG our customers aren’t limited to just who’s available at the time, they get a team built with their specific goals in mind.

Team Curation

We leverage an 18 year history of attracting and retaining top talent and utilize:

  • A direct sourcing model with 15+ industry specific recruiters
  • A proactive approach, we’re always on top of core skills in core geographies
  • Advanced technical screening with industry experts

On-boarding

On-boarding is focused on reducing the time to productivity for technical resources in the customer’s environment. In our experience, what starts well tends to end well and vice versa.

On-boarding

We collaborate with our customers and leverage our past experiences to:

  • Identify system and tool access requirements
  • Document and train resources on tools, SOP’s
  • Ensure all team members understand and align culturally

Performance Management

With a focus on Performance Management customers can be assured the CSG team is actively managed to a high standard. It’s results that matter most in any engagement and talented developers want constructive feedback.

Performance Management

We use the Table of Programs (TOP), project timelines, and team composition to provide metrics and active coaching on the following:

  • Quality of deliverables
  • Timeline adherence
  • Rework required

Capacity Planning

With effective Capacity Planning team size and composition can be calibrated to meet the changing demands of the business. We believe in tight collaboration with our customers on both the work at hand as well as what’s around the corner.

Capacity Planning

To effectively flex capacity up or down with business demand we:

  • We assess workflow and team capacity reconciliation.
  • We monitor progress regularly and provide visibility to customer stakeholders
  • Leverage our proactive sourcing model to identify top talent well in advance of the need

Administrative Support

Administrative support can take many forms but the goal is to relieve customers of tasks that slow their internal resources down when engaging with a partner.

Administrative Support

With dedicated project management and tools, we’re able to:

  • Collect hours worked and tasks performed enabling us to provide time and activity tracking for each team member.
  • Provide invoicing at the individual and team level based customer need.
  • Provide metrics and a graphical representation of the remaining work on a project vs. the timelines.

Accountability.

A Stakeholder in the Outcomes You Seek.

With CSG’s customized Biometrics FSP model, your company will have reduced management burden as we will manage all portions of your Biometrics project. We use a direct sourcing model which is core to the heritage of CSG. This model allows us to curate a team of unique and specialized professionals for each program type. We custom select and verify that all candidates for the team are qualified for your specific program needs. Our Functional Service teams allow the continuity of dedicated team members and productivity for the entire length of your project. Your company’s projects and trials will thrive with improved quality and consistency.

Flexibility.

Our Biometrics FSP solutions allow for flexibility in your projects, contractual terms, engagement models, and cost strategies to carefully adjust to your exact needs. We work with clients to make sure the FSP solutions remain within budget while also providing high quality and consistent work. Our clients have complete control over their projects and can use their own SOPs and systems. This not only reduces overhead cost but allows consistency of studies and submissions to the FDA. CSG has created this unique and flexible space between typical staffing and outsourcing to ensure our solutions are carefully calibrated to meet your needs.

Reporting.

We provide transparent delivery of our Biometrics FSP offering. We offer our clients clear KPI measurements and reporting, honest and open interactions, and quarterly business reviews to confirm project and team are on schedule.