• Process and document review
• preparation of for-cause-audit
• providing of recommendations on eCOA data usage and future preventive actions

Business Consulting to General Managers, Interim Management Customer Support, Interim Management HR

• Process and document review
• coaching
• leadership and strategy workshops
• inititation of company restructuring
• cross-functional project initiation
• recruitment of leadership personnel

Design, development and process definition for resource and metrics database for global R&D Informatics Department

• Assisted client to design and develop a global resource and
  metrics database including development of business
  requirements
• interactions with technology service provider to allow for best results for client

Project Management of a major update of the global Clinical Data Repository system

• IT project management
• stakeholder management
• vendor management
• facilitation, encouragement and support of process re-design

Design of processes, tools and background databases for a Risked Based Monitoring concept

• Defined robust Risked Based Monitoring processes, including tools and background databases.
• Conceptualized KRIs, good documentation practices and stress tested system to prepare implementation.
• Coaching of personel involved.

Workflow optimization of global pharmacovigilance operations

• Workflow and technology evaluation
• identification of process gaps, system flaws and interdependcies of issues
• development of a set of recommendations for process improvments and technology adjustments

Review of current practice in the global Data Management department

• Review of current Data Management processes, CRO
  interactions and development of a set of recommendations.
• Development of process maps for new, state-of-the art
  processes, creation of a new Data Management SOP and a set of corresponding Guidelines

Assessment of global Data Management Department (360+ people, 3 major sites) and preparation for future challenges

• Review of processes, roles, tools, the organization of work and vendor management.
• Face-to-face interviews in USA, Europe and India on executive and working level within and outside of Data Management.
• Provisioning of a set of recommendations.

Development of a process overview for global R&D Informatics Department

• Review of all major clinical R&D processes and creation of
  corresponding process maps.
• Face-to-face interviews with process owners and stakeholders.
• Provisioning of a set of recommendations.

• Process and document review, interviews with globally distributed and cross-functional project stakeholders.
• Preparation, facilitation and documentation of vendor evaluation and vendor selection workshops.

Revision of Study Start- up processes. Development of and implementation support for a new Vendor Oversight Management strategy for Statistics, Medical Writing and Data Management

• Interviews with cross-functional stakeholders in US and Europe.
• Development of new cross-functional Study Start-up processes.
• Multiple workshops to define business needs and actual new strategy for Vendor Oversight Management.
• Preparation and conduct of two role-playing workshops on Vendor Oversight Management for all department members.
• Individual coaching of selected department members to ensure proper implementation.

Evaluation, selection and implementation of a new global EDC system

• Interviews with globally distributed and cross-functional project stakeholders.
• Preparation and facilitation of workshops to define company's EDC business requirements, live system review and reference visits to other vendor clients.
• Facilitation of Vendor Selection meeting.
• Preparation, facilitation and documentation of multiple process review workshops with cross-functional
  representation to define revised processes.
• Developments of project communication plan, training material and SOPs.
• Preparation and conduct of a "Mock Trial" as preparation for system implementation.

Assessment and re-design of the Global Clinical Development organization including Clinical Operations, Pharmacovigilance, Epidemiology, Statistics, Medical Writing, Data Management, Database Programming.

• Review of eClinical strategy including EDC system versioning and electronic patient diaries
• Interviews and multiple workshops on the revision of the cross-functional Data Cleaning processes.
• Preparation and facilitation of a SWOT workshop for the Epidemiology department. Development of alternative operating models for Statistical Programming.
• Review of Statistical Programming and DB Programming processes (mock data handling, additional analysis, programming concept, lab data handling) and recommendations for changes.
• Individual coaching of selected team members on revised processes and change management.

Assessment of the Global Data Management organization (300 people, 5 locations, 3 continents) and development of a future concept for Data Management

• Interviews with globally distributed department members at all levels and with Data Management customers.
• Detailed review of processes, metrics and tools.
• Workshop with internal "high potentials" on their perspective of desired future state.
• Provisioning of a detailed report with description of strengths, areas for improvement and potential development needs.

Evaluation of the need and potential selection of a Clinical Trial Management System

• Process and document review and interviews with globally distributed and cross-functional project stakeholders.
• Recommendation to develop a sponsor specific application.