BOUTIQUE SERVICES
For Clinical Development
- ComplyWell Solutions can review the study protocol, operational documents (e.g. SOPs, Monitoring Plans / Reports, Protocol Deviation Log, IP Accountability and Temperature Monitoring Log, DM Query Log, SAE Log, Central Lab Reports, etc.) initially and on an on-going basis and alert you on the potential quality / compliance issues before they become a real problem.
- ComplyWell Solutions can support you while selecting a vendor for clinical, DM, pharmacovigilance, etc. activities and help you putting in place robust operational plans (or manuals) and quality agreements. We can also monitor vendor performance on your behalf by overseeing the SLAs, KRIs and KPIs while you focus on the core development activities.