Full-Time Equivalent (FTE) Capabilities
Altasciences is a forward-thinking, mid-size contract research organization with over 30 years’ experience, offering pharmaceutical and biotechnology companies a proven, flexible approach from lead candidate selection to clinical proof of concept.
We facilitate and expedite delivery of our comprehensive suite of Research Support Services through a Full-Time Equivalent agreement (FTE) option that offers maximum flexibility, and ensures you have consistent access to our experts through the different phases of your drug development program.
Altasciences’ FTE Advantages
- Increased resource flexibility and enhanced ability to manage workload fluctuations
- Quick and easy access to specific skills/expertise through our world-class team
- Readily accessible training resources
- A flexible approach adapted to your specific needs
Our FTE offering provides flexible, accessible support in the following areas:
Organizational
- Due diligence assessment
- Post-acquisition integration
- Vendor/subcontractor qualification and management
Scientific
- Clinical protocol development
- Clinical program design and strategy
- Regulatory science and strategic guidance
Trial Services
- Project/program management
- Biostatics
- CDISC/SEND
- Data management
- Clinical monitoring
- Site feasibility and qualification
Quality and Compliance
- GxP Training
- Performance of independent GCP, GLP or GCLP system and/or study-specific audits
- Pre-approval inspection (PAI) readiness assessments
- PART 11 compliance assessments
- Data integrity assessments
Compliance Remediation
- Review of responses and support for remediation in response to FDA 483 and warning letters
- Post-submission regulatory deficiency remediation
- Independent third-party review of:
- Deviation investigations
- Validation reports
- Laboratory investigations
- Method validation reports
Altasciences offers integrated, full-service solutions, all customizable to specific sponsor requirements. Including preclinical drug development, clinical trial services, precision bioanalysis, and manufacturing and analytical services, seamless integration is achieved through proactive internal and external communication, ensuring that you will not need to repeat the same information twice – Tell Us Once™, and we’ll take care of the rest.
To learn more about our senior management, visit the Our Team page, which includes a link to detailed biographies for many of our experts, across all our services. We have the knowledge, the expertise and the experience to deliver the early phase development solutions you need, for stand-alone projects or full development programs, including FTE arrangements for many of our Research Support Services.
Visit our Resource Center to see a variety of educational webinars and informational videos about our services, and educational webinars. In the Resource Center, you can also access to our scientific journal, posters, audiobooks, newsletters, electronic bulletins, blogs, and more.