S-Clinical is a full service Contract Research Organization (CRO). We offer wide range of Clinical Research Services to Biotech and Pharmaceutical Companies across the USA, Canada, EU, South Africa, and Asia (India, China, UAE) regions.
• Offers cost effective high quality services
• Ideal for small and mid-sized biotech companies to meet budget needs
• Expertise for your trials around the globe including India, China, UAE and South Africa regions
• Wide range of therapeutics area experience including but not limited to Oncology, Immunology, Rare disease, Dermatology, Cardiovascular, CNS, GI, etc.
• Masters and PhD level staff each with at least 15+ years of industry experience
• Trial document preparation (IB, Protocol, ICF)
• Regulatory submission – Central and Local (USA, EU, Asia, UAE, South Africa)
• Site Start-up
• Monitoring
• Project Management – CTMS
• eTMF Setup and Maintenance
• Site Audits
• Third Party Vendor Management
• Data Management Plan (DMP)
• Database Design and Management
• eCRFs
• CCGs
• Medical Coding
• Database Lock
• Data Transfer
• Statistical analysis plan (SAP)
• CDISC compliant SDTM and ADaM datasets
• TLFs
• IB and Protocols
• CSRs and Synopsis
• Patient Narratives
• Study Reports (Clinical and Non-Clinical)
• Rregulatory Application (IND, NDA, BLA) in eCTD-format
• Regulatory Submissions Using eCTD Format
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