Clinical Development Services
As a trusted partner in your development operations, Actalent aims to be your preferred vendor for your embedded and outsourced needs. We provide solutions to your shifting business needs and priorities.
Actalent partners with life sciences companies to drive regulated product development through our comprehensive FSP offerings.
Our FSP solution enables life sciences organizations to scale and supplement core functions while outsourcing non-core functions throughout the product life cycle of a drug, device, diagnostic or combination products. We deliver high-quality work that seamlessly integrates with your current operations, using either your internal tools, systems and procedures or leveraging Actalent’s ICH-GCP compliant tools, systems and procedures.
Who We Are
Founded in 1981 and headquartered in Maryland, we are a global FSP clinical development services organization.
Recognized as the largest clinical talent services provider in the U.S. for multiple years, we have four global FSP delivery centers.
Our team possesses deep technical expertise, offering not just talent, but genuine experience in clinical development, regulatory and quality, medical safety, and the product development life cycle.
Our Solutions
- Clinical trial management
- Quality assurance
- Regulatory affairs
- Medical affairs
- Medical writing
- Biometrics
- Data management
- Site support and coordination
Our Services
We offer a wide range of services through our FSP model. Our CPMs, CRAs and study start-up specialists operate in over 40 countries, ensuring your sites are prepared and motivated to meet patient recruitment targets. Our data managers, programmers and biostatisticians ensure your EDC database is ready, with data cleaned and reported in the shortest possible timeframe. Additionally, our quality auditors and regulatory specialists help you maintain compliance and gain a competitive advantage.
FSP Delivery Models
Project-Based
For clients requiring functional resourcing support on projects with clearly defined milestones, timelines and deliverables, we provide tailored project-based solutions to meet your specific requirements.
Full Functional Outsourcing
For clients requiring ongoing functional resourcing support, we create and manage dedicated functional teams (e.g., monitoring, data management).
Hybrid-Based
For clients requiring supplemental resourcing within a function, we provide resources who you directly manage the day-to-day operational tasks for, while Actalent handles the line management of those resources.
Our Expertise in Clinical Development Services
- IIS management
- Global and country project management
- Monitoring and site management
- Study start-up support
- Vendor selection and management
- Ethics submission
- Medical writing (Clinical protocol, Clinical study report)
- Publication and manuscript
- Pharmacovigilance and drug safety
- Medical monitoring
- Safety assessment
- Real world evidence (RWE)
- QMS build/refresh
- GxP auditing (Clinical site, Vendor Internal, Inspection readiness)
- CAPA
- Risk management
- Clinical trials CQA support (Training, Doc control, CSV)
- Regulatory affairs
- Technical writing
- Preparation of regulatory dossier and submission
- PV reporting
- Regulatory compliance
- Investigational clinical trials submission support (CTA/ITA, IND/IDE)
- Data management (DB design, DMP, QC, DBL)
- Biometrics (Statistical programming, Biostatistics, TLFs)
- Safety data review
- Reporting dashboard
- Real world data (RWD)
- Research coordination
- Training
- Informed consent writing/review
- Data entry
- CRA visit support
- Site administration
- Invoicing and reconciliation
- Quality and audit support
- Materials management
Problems We've Solved
Actalent supports life sciences clients with varying sizes, footprints and market shares, including some of the most recognizable companies in the world. Through these successful partnerships, we've developed solutions that have supported:
- Clinical and regulatory gap assessment and support
- Global clinical operations study execution and monitoring
- Regulatory dossier writing and submission
- Rescue clinical trial support
- Data management systems validation and training
- Internal and external GxP auditing
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Success Story
Actalent Helps Client Maintain $20 Million of its Market Share by Securing Approval of its EU Product LinesLeader in Sports Medicine and Rehab Products Successfully Navigates Strict New EU Medical Device Regulations (MDR)
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Article
Assessing CRA Monitoring Performance in a Digital WorldHow does your company assess the performance of clinical research associates to ensure quality and safety standards are consistently upheld?
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Article
Aggregating Data Sources - Enhancing Clinical Trial ResultsWhile data gained through clinical trials is significant at the individual trial level, its value increases exponentially when the information is proactively aggregated, shared, cleansed and analyzed.
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Delivery Centers
With unmatched expertise and knowledge, access to top-tier talent, technical resources and an expansive vendor network, our clinical development services can be delivered through a combination of on-site/embedded, hybrid, remote, near-shore and off-shore locations. Our FSP delivery centers are located in the following areas:
Quality Assurance and Privacy
Quality. Integrity. Trust
Actalent strives to deliver on time, on budget and on schedule every day.
We know how hard it is to select the right FSP vendor for your product development needs. This is why we work hard from the beginning all the way to the end of our FSP programs to keep your trust and confidence in our service offerings. Actalent is with you every step of the way.
Contact Us
Interested in working with Actalent?
Please provide details on your needs in clinical development services below.
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