We are dedicated to the success of our clients by providing extensive support through a network of experienced professional veterans in leading positions from the international Big Pharma industry to cover the entire product life cycle process.
Sacura is your best choice for a service partner in terms of speed, quality, and cost efficiency in clinical development.
Working with our partners in a long-term successful partnership oriented cooperation, we are able to serve as a one-stop shop with the complete spectrum of services for your needs.
With our proven structure and management skills we have in the past demonstrated a measurable benefit for our clients in an earlier completion of their development projects.
Specialties/Services:Clinical Trial Management, Feasibility Studies, Clinical Study Set-up/Implementation, Monitoring and Reporting, Document Management, Data Management and Biostatistics, IIT support, Get your sites ready for Audits and Inspections, Consultancy for clinical programs
Clinical Development Consulting
Our experienced team supports Biotechs and academic institutions planning their first clinical study withexcellent support and best practice consulting, We provide:
- Management consultancy forclinical development programs for Biotech, academic institutions and MD companies
- Extensive support with a networkof veterans previously experienced in leading positions in the Big Pharma industry
- One-stop-shop service covering thecomplete life cycle and development process from Target Product Profile (TPP) to the market access
- Continuous risk management, Ad-hoc support, Problem solution and Preventing Action. Our teams are experienced in the successful management of Rescue Studies.
Clinical Project Management
We are acting with flexibility, the experience of more than 115 clinical trials and open communication with you in a joint team to ensure your milestones by managing:
- Compilation of project management plan and definition of key parameters (milestones,budgets, resources, logistics, project tools)
- Budgeting and cost management of development projects. Resources management and co-ordination of all third party providers contracted
- Quality is the backbone of a clinical trial. Our systematic approach ensures high quality data and is the basis of our daily business.
- A proper risk assessment is used to plan the details of trial management and the approach to and extent of monitoring and controlling the trial
Clinical Study Execution
- Selection and evaluation of key opinion leaders (KOLs)
- Coordination of Investigators and suitable study centers including pre-study site assessment
- Budget negotiation, drawing up and establishment of contracts for study centers and third party providers
- Submission/reporting to authorities (Competent Authorities, ECs/IRBs, regional boards, etc.)
- Planning and performing of kick-off meetings
- Implementation of study within the study centers including electronic systems
- Supply of investigational product and non-study drug materials and equipment to the centers
- On-site Monitoring, Clinical Monitoring, Centralized Monitoring, Data Monitoring
- Personnel support and site assistance
- Clinical quality assurance, preparation for audits and on-site GCP training
- Support for implementation of the study in the daily work of the site
- Maintenance of TMF/eTMF and ISFs, translation and validation of study documents, proving a central electronic platform for team networking and documentation
e.tract is a web-based online platform for secure collaboration of all partners in clinical trials. The software simplifies editing, sharing, tracking and archiving of study documents. Central domains of this platform are individually structured workspaces (eRooms), an electronic Trial Master File (eTMF) and Investigator Site File (eISF). e.tract is characterized by:
• Use of the current DIA TMF Reference Model, version 2.0
• Easy handling, no increased training requirements
• Clear roles and responsibilities, improving the cooperation between involved partners
• Increased transparency reduces undue information sharing in the working groups
• Standardization of the collection, storage and management of TMF documents, consistent naming conventions
• TMF structure provides clear descriptions and easy navigation
• Simple features to search for documents via open text search, tags, descriptions of the documents, indexes, etc.
• 21 CFR part 11 compatible •Ensures completeness and quality of the TMF
• Real time status
• Continuous mobile availability for access with smartphones, tablet computers, etc.
• Easy "one click" archiving of the eTMF