Broad Range Of Excellent Services
Our Team are proud to deliver the very highest quality
The CS Pharma team are experienced in the development of pharmaceutical products, supporting a wide range of capabilities for all therapeutic areas.
Our extensive experience has enabled CS Pharma to assist clients in the successful planning and delivery of product portfolios. CS Pharma provides strategic input and support from original concept, pre-clinical development, manufacturing and analytical characterisation, pre-clinical studies and regulatory activities, first time into human and later-stage clinical trials, through to Competent Authority submission, registration and marketing. Our teams work cohesively with clients to oversee an agreed programme, ensuring the project is performed on time and within budget with no compromise on quality.
- Project Leadership
- Development strategy planning and execution
- Protocol development and review
- Management of programme timelines and resources
- Site identification and feasibility
- Site qualification and initiation
- Site budget and contract negotiations
- Management and facilitation of IRB/IEC submissions
- Study document generation
- Selection of contract manufacturers and analytical labs
- QP support
- Identifying pre-clinical partners
- Pre-clinical study design, placement and oversight
- Toxicologist support
- Clinical product development strategy
- CRO contract
- Biometric support including Biostatistics and Medical Writing
- Regulatory support
- Vendor selection and contract negotiation
- Legal Services
- Partner and fundraising support
- Identification and assistance with grant applications
- Informatics validation
- Site Monitoring and reporting
- Remote monitoring
- ISF and eTMF management
- Audit of potential partners
The CS pharma clinical operations team are recognised for comprehensive clinical trial monitoring and site management services, from initial feasibility through to closeout, providing bespoke, flexible and highly cost-effective support.
Our clinical monitoring team comprises of an extensive network of global CRAs who are experienced with all phases of clinical research and therapeutic areas.
CS Pharma can provide global insights strengthened with Key Opinion Leaders and study personnel supported by our study setup team.
From concept to project activities, site selection, clinical trial protocol review, ethics and regulatory submissions CS Pharma will provide seamless support.