Choosing the right biometrics partner is a critical decision that can significantly impact your clinical development timeline, budget, and ultimate regulatory success. This comprehensive checklist will guide you through the essential criteria to evaluate potential biometrics partners and help you make an informed decision.
Experience & Expertise
☐ Therapeutic Area Experience
● Does the partner have specific experience in your therapeutic area?
● Can they provide examples of similar studies they've supported?
● Do they understand the unique data challenges in your indication?
☐ Regulatory Track Record
● What is their submission success rate with regulatory agencies?
● Do they have experience with FDA, EMA, PMDA, and other relevant authorities?
● Can they provide references from sponsors regarding regulatory interactions?
☐ Technical Capabilities
● Do they have certified expertise in required statistical methodologies?
● What is their approach to complex study designs (adaptive, Bayesian, etc.)?
● Do they have experience with specialized analyses relevant to your program?
☐ Staff Qualifications
● What are the qualifications of the senior team that would support your program?
● What percentage of staff have advanced degrees in relevant fields?
● How do they ensure staff remain current with evolving methodologies?
Operational Excellence
☐ Project Management
● What methodology do they use for project management?
● How do they track and communicate timelines and milestones?
● What escalation procedures are in place for potential issues?
☐ Quality Systems
● What quality control and assurance processes do they implement?
● How do they validate their deliverables?
● What metrics do they track to ensure quality?
☐ Technology Infrastructure
● What software platforms and versions do they support?
● How do they ensure data security and integrity?
● What level of system validation do they maintain?
☐ Capacity & Scalability
● Do they have adequate resources to support your timeline?
● How do they handle resource fluctuations for your program?
● Can they scale up quickly if program needs change?
Strategic Partnership
☐ Consultation Approach
● Do they provide strategic input or simply execute tasks?
● How do they approach protocol design and optimization?
● Will they challenge assumptions when appropriate?
☐ Communication Style
● How frequently will you receive updates?
● What is their escalation process for critical issues?
● Do they communicate proactively or reactively?
☐ Flexibility
● How do they handle mid-study changes or amendments?
● Can they accommodate different engagement models?
● How adaptable are they to sponsor-specific processes?
☐ Knowledge Transfer
● How do they document their processes and decisions?
● What training do they provide to sponsor teams?
● How do they ensure continuity if personnel changes occur?
Compliance & Standards
☐ Regulatory Compliance
● Are they familiar with current regulatory guidance?
● How do they keep current with evolving requirements?
● What is their approach to regulatory interactions?
☐ Data Standards
● What is their experience with CDISC standards (SDTM, ADaM)?
● How do they implement standardization across studies?
● What processes ensure consistent implementation?
☐ SOPs & Work Instructions
● Are their SOPs comprehensive and current?
● Have their procedures been successfully audited?
● How do they ensure consistent SOP implementation?
Commercial Terms
☐ Pricing Model
● Is their pricing transparent and predictable?
● How do they handle change orders and scope modifications?
● What guarantees do they provide regarding deliverables?
☐ Contracting Flexibility
● What engagement models do they support?
● Can they accommodate FSP, fixed price, or hybrid models?
● Are they willing to structure risk-sharing arrangements?
☐ Geographic Coverage
● Do they have resources in relevant time zones?
● Can they support global studies effectively?
● How do they manage international collaboration?
Cultural Fit
☐ Team Dynamics
● How well do their team members interact with yours?
● Do they understand your company culture and working style?
● Are they responsive to your communication preferences?
☐ Problem-Solving Approach
● How do they approach unexpected challenges?
● Can they provide examples of creative solutions?
● Are they proactive or reactive in identifying issues?
☐ Long-Term Relationship
● Do they view this as a transaction or a partnership?
● How have they grown relationships with other clients?
● What is their client retention rate?
Evaluation Process
Before the Selection:
1. Create a weighted scoring system based on your specific priorities
2. Request detailed case studies relevant to your program
3. Speak with references, particularly from similar studies
4. Meet with the actual team that would support your program
5. Consider a small pilot project to evaluate performance
Red Flags to Watch For:
● Overpromising on timelines or deliverables
● Inability to provide specific examples of similar work
● High turnover of key personnel
● Reluctance to discuss past challenges
● Limited understanding of your therapeutic area
Final Decision Matrix
Create a comprehensive evaluation matrix with:
● Weighted scores for each category based on importance to your program
● Input from multiple stakeholders (clinical, regulatory, data management)
● Both quantitative metrics and qualitative assessments
● Consideration of both immediate needs and long-term partnership potential
This checklist is designed to be customized based on your specific program needs. We recommend prioritizing the criteria most relevant to your therapeutic area, development stage, and organizational structure.
Download our companion template: "Biometrics Partner Evaluation Scorecard" to document your assessment process.
Our team of biometrics experts offers complimentary consultations to help with your clinical development needs. We'll assess your protocol, analysis plan, biometrics resources, and vendor gaps—at no cost.
Click here for a free consultation or contact: Suling Zhang, VP of International Operations and Business Development
Email: suling.zhang@gcp-clinplus.com
Phone: +1 609-255-3581
________________________________________
About GCP ClinPlus
With 22 years of experience, 2,200+ successful projects, and 160+ NDA approvals from FDA, NMPA, and EMA, GCP ClinPlus offers unparalleled biometrics expertise. Our US team brings 30+ years of global regulatory experience to every engagement.