Expertise

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• Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Trial Master File (TMF) 
• Site management, including SQVs, SIVs, IMVs and COVs
• Driving subject enrollment
• Clinical trial budgeting
• Clinical Quality Assurance
• Regulatory compliance
• Clinical Research Associate oversight and management
• Oversight and management of Clinical Research Organizations (CROs)
• Create and maintain study documents; (e.g. Clinical Investigational Plans (CIPs), source document worksheets, Standard Operating Procedures (SOPs))

Deep experience in the medical device industry managing complex projects with diverse, cross-functional teams of 20+ members.

• Comprehensive life-cycle management
• Earned value management methods and templates
• Methods to create Work Breakdown Structures and translate work packages into Jira Epics and Stories
• DHF management and DMR versioning
• Burn-down/Burn-up charts
• MS Project/Smartsheet scheduling
• Stakeholder identification, analysis and management

K&N Consulting continually identifies, monitors and mitigates risks through risk registers.  When the risks are realized, K&N transfers the risk to an issue log with an updated monitoring and action plan.

Regarding Change Management, many companies that have steering committees tend to focus on providing high-level updates rather than focusing on the changes that are needed to address risks and issues.  K&N Consulting assembles a Change Control Board with various stakeholders to manage risks and associated changes to scope, schedule, budget, Quality and/or resources.

  Expertise with  ISO 13485, ISO 14971, IEC 62304, ISO 10993

K&N Consulting has collaborated on and signed Term Sheets, Operating Agreements, Capitalization Tables, and other organizational documents.  Additionally, K&N Consulting has robust templates for pro-forma Income Statements, Balance Sheets, Operating Profit.

K&N Consulting approaches decision making from many angles, including implementing the ground-up Kepner-Tregoe method and a high-level Decision Tree analysis.  Other methods include Sensitivity/Tornado Chart analysis, Business Driver analysis, multi-generational product planning.

Trained by IDEO designers and Stanford professors in Human Centered Design to target the nexus of Desirability (end-user pull), Viability (business and economics) and Feasibility (technical capabilities).

K&N Consulting is adept at translating Voice of Customer and User Needs into system level product requirements (Product Requirements Document), lower level requirements and verifying requirements and validating User Needs.

K&N Consulting has expertise is Usability and complying to AAMI HE75 standards, such as creating a Human Factors Plan, designing formative and summative studies and overseeing the development of User Interfaces and User Experience (UI/UX).