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Project Examples
Vendor selection (EDC / ePRO)
Cross-functional stakeholder interviews; business case writing; RFI and RFP process, vendor evaluation and selection; management presentation; budgeting and contracting.
EDC and ePRO implementation
Interface between sponsor and vendor, analysis and adjustment of business processes and application features, feasibility and formal testing, creation of trial specific SOPs for pilot studies.
Business support unit (“EDC office”)
Mentoring of study teams during set-up, conduct and close-out phase, “translator” between study team and vendor staff, creation of trial specific SOPs, UAT support.
Training (EDC, ePRO, CTMS)
General and study-specific trainings for internal and external users of eClinical applications. Determination of training scope, preparation of training material, global training rollout.
Business Process Re-engineering
Analysis of EDC related processes within a global data management department and interfaces to external resources from EDC vendor and CROs. Project lead to establish and implement new processes. Communication to internal stakeholders and external partners.
Implementation of CTMS middleware
Development of a CTMS middleware connected to Impact and other data sources. Definition of user requirement specification, vendor briefing, project management, UAT and approval. Report specifications, development management, UAT and approval. Supervision of global rollout, user training and support.
Management Reporting
Development and maintenance of a study management tool for monitoring of patient compliance. Creation of data analysis and management reports.
Evaluation of coding tools for EDC integration
CDISC introduction / evaluation on management level
SOP writing / maintenance related to use of eClinical applications
Involved Technologies
Implementation and Efficient Use of eClinical Processes, Applications and Data Standards
Do you feel your business should be supported by eClinical applications and industry standards like CDISC?
Do you already use eClinical systems like EDC, ePRO, yet doubt that you’re really getting the expected benefits?
Do you notice that cross-functional project teams do not always speak the same "language"?
Do you need active contribution to manage your projects?
We have successfully helped companies identify areas of improvement and define gaps that need to be bridged. We’ll work together with you to select the appropriate means via process optimization, selection and implementation of software systems or training. You’ll never be left alone with just a pretty deck of slides! ClinFusion has been working in the industry for many years in various roles as an architect, vendor, implementer and user. We will share our different perspectives to solve your problems. Get in touch with us!
Project Examples
Medical device development
Patient community platform for medical device data processing (incl. Smartphone)
user requirements collection and processing
Standards management tool (CDISC / Rave)
Sharepoint
Site qualification tool
Web based training platform (OTC)
Development and Customization of eClinical Applications
Do you feel overwhelmed by the complexity of software tools?
Do you feel lost in the diversity of data standards and acronyms?
Do you need software solutions that can solve more than just one isolated problem?
We have successfully managed hardware and software development teams and external system providers to deliver solutions that met our clients' expectations. Our in-depth understanding of your business will help you define the requirements to support your entire scope of business, not only specific “islands” of improvement. People, tools and standards should all interact in the most efficient way.
Get in touch with us!
Project Examples
Implementation of CRM / BCM
Formation of BD department incl. Process definition and implementation
Management of contract to contract cycle
Acquisition measures (marketing: events, etc.)
Implementation of contract structures
Conception of telemedical company
Market potential analysis for medical device
Public funds
Funding (VC, BA, public funds)
Establishment of accounting system
Corporate form (GmbH => AG)
M&A transition
Business Plan
We have successfully accompanied companies throughout all stages of their growth strategies in the life sciences industry: From initial funding, the definition and financing of expansion strategies, to the very "old fashioned" way, increasing sales. We have overseen all types of business development activities in Europe, North America and Asia. Our experience and our network will help you grow.
Get in touch with us!
Financial Growth through Investments and Strategic Marketing & Sales Activities
Do you feel that your products deserve a higher degree of market acceptance?
Do you need more financial flexibility?
Do you have a brilliant product idea you need to make reality?