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According to Hussain Mooraj of AMR Research. ““Although companies are looking to new products to fuel future growth, the complexity, regulatory demands, and disconnected demand-sensing and product supply processes result in an extended and expensive development process. The conundrum is how to accelerate the speed of development and drive down supply chain costs at the same time.”
We can help.
Electronic Data Capture (EDC) Implementation – We can help you build effective solutions to gain quick EDC adoption success and significant return on your investment with services that include:
- Vendor assessment and selection
- Strategic planning and project management
- EDC software implementation and validation
- Business process redesign
- Policy/procedure development and updates
- Training, re-skilling, and organizational alignment
- Change management
Quality Assurance – We can help you assess, audit, and validate your pre-approval clinical development initiatives achieving both regulatory compliance and operational efficiency with services such as:
- GCP compliance audits
- SOP development/review
- Mock FDA audits
- 483/warning letter remediation
- Computer system validation
- Vendor, project, and program audits
- Overall QA knowledge transfer/training/education
LIMS Implementation – We can help you leverage the LIMS investment you’ve made within your manufacturing environment to gain substantial efficiencies and within your preclinical/development operations. Our services include:
- Business case justification/ROI forecasts
- Vendor assessments and selection
- Project management
- Process design/redevelopment
- Technical development
- Systems and instrument integration/configuration
To learn more about our Clinical Development solutions, call us toll free at 1-800-652-4274 or send an email to marketing@clarkstonconsulting.com.
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