Clinical Services
Bringing new regulated healthcare products and medicines to market for patient needs requires expansive funding, high technical competency, and the ability to navigate a myriad of complex regulatory environments.
Actalent is positioned to drive development.
Our clinical services capabilities align with our client's initiatives to effectively and efficiently progress through the various phases and stages of development. The Actalent solution adheres to the cost, quality, and schedule for project and program management to best meet our client's business needs and challenges.
Who We Are
- PMP Certified Project Managers
- Certified Clinical Research Associates (CCRA)
- Certified Clinical Research Professionals (CCRP)
Memberships
- The Society of Clinical Research Associates (SOCRA)
- The Association of Clinical Research Professionals (ACRP)
- The American Medical Writers Association (AMWA)
- The Regulatory Affairs Professionals Society (RAPS)
Certifications
- ISO 13485
- Regulatory Affairs Certification (RAC)
Problems We’ve Solved
We support a variety of clients who range in size, footprint, and market-share across industries. Our clients are industry leaders and relentless innovators dedicated to solving tomorrow’s problems. Through these successful partnerships, we have developed and implemented clinical services solutions relating to:
- Global regulatory compliance initiatives
- Bioinformatics and data management projects
- Therapeutic-specific global clinical research projects
- Precision medicine research
- Infectious disease research
- Therapeutically aligned study projects
Our Expertise
- Study start-up activities
- Site selection
- Country project management
- IIS management
- Ethics submission
- Site management
- Medical writing
- Clinical protocol
- Clinical study report
- Pharmacovigilance & drug safety
- Publication support
- QMS build and refresh
- GxP auditing
- Risk management
- Vendor selection
- Validation
- ECO and CAPA management
- Data management
- Biostatistics
- SAS programming
- Technical writing
- Preparation of regulatory dossier & submission
- PMS & PMCF
- PV reporting
- Medical device regulatory strategy
- Regulatory compliance
- Case processing
- Quality control/medical review
- Individual case safety report (ICSR) submission
- Periodic safety report submission (FDA, EMA, Health Canada, etc.)
- Literature review and surveillance
Industries We Support
Consumer and
Industrial Products
Life Sciences
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Case Study
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 and technical resources, and expansive vendor networks, our clinical services can be delivered through a combination of hybridized (off-site, remote, combined), outsourced, and in-sourced/onsite solutions and typically take the form of a Functional Service Provider (FSP).
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