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Clinical Trials Project Management for Medical Devices

Posted on August 5, 2016 | Categories: Clinical Trials, HealthCare IT, Program and Project Management | Posted by: admin

Clinical Trials Project Management for Medical Devices

 

Project Management Stages for Clinical Trials for Medical Devices 

 

  • Ideation & Planning
  • Research & Analytics
  • Coordination with CROs
  • Design & Protocol
  • Development & Documentation
  • Testing & Phases
  • QA & Compliance
  • Strategy & Communication
  • Regulatory & Approval
  • Go-to-Market (Phase 4)

Clinical Trials for Medical Devices – Key Terms & Phases

 

  • PMA – Pre Market Approval Application
  • Medical Device Classes – I, II, III
  • Stages for PMA device – Pre IDE on Animal Testing, IDE (Investigational Device Exemption) on Human Testing (Clinical Trial), PMA

 

Clinical Trial for Medical Devices

 

  • Wound Closure
  • Injection Devices
  • Catheters
  • Balloon & Stent Systems
  • Orthopedic Implants

 

Clinical Trials – Tools & Technology

  • CDMS Types – Paper based or Electronic. Usually Double Data Entry strategy is followed
  • Clinical Data Management System (CDMS) – to manage the data of a Clinical Trial / Research
  • Clinical Trial Management Systems (CTMS) viz. Allegro CTMS, ClinPlus, Veeva etc.
  • Clinical Trials Data Format – XML, TXT, CSV, Matlab files or System Specific Files
  • Electronic Data Capture (EDC) – via Cloud, Web & Portal
  • Electronic Trial Master Files (eTMF) for storage and collaboration viz. Veeva, SureClinical etc.
  • MS Excel for Spreadsheet
  • MS Excel for Visio
  • MS Project for Program Management
  • MS Sharepoint for Access & Collaboration
  • MS Word for Documentation

 

Leading CROs for Medical Device Testing

 

 

Contact Manish for Clinical Trial PM at 646.644.3049 or manish@techcusp.com

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25 Largest Health Systems in America

Posted on August 5, 2016 | Categories: Health Insurance, Health System, HealthCare, HealthCare IT | Posted by: admin

25 Largest Health Systems in America

 

Here are the 25 largest integrated health systems, according to SK&A’s report.

 

  1. Community Health Systems (Franklin, Tenn.) — 2,224 total facilities
  2. Ascension Health (St. Louis) — 2,098
  3. HCA (Nashville, Tenn.) — 1,719
  4. Trinity Health (Livonia, Mich.) — 1,705
  5. Tenet Healthcare (Dallas) — 1,061
  6. Kaiser Permanente (Oakland, Calif.) — 1,045
  7. Carolinas Healthcare System (Charlotte, N.C.) — 936
  8. UPMC (Pittsburgh) — 859
  9. Partners HealthCare System (Boston) — 788
  10. NewYork-Presbyterian Healthcare (New York City) — 732
  11. Catholic Health Initiatives (Englewood, Colo.) — 719
  12. Mercy Health System (Chesterfield, Mo.) — 706
  13. Baylor Scott & White Health (Dallas) — 683
  14. Northwell Health (New Hyde Park, N.Y.) — 670
  15. Adventist Health System (Altamonte Springs, Fla.) — 636
  16. Sutter Health (Sacramento, Calif.) — 622
  17. Providence Health & Services (Renton, Wash.) — 579
  18. Universal Health Services (King of Prussia, Pa.) — 571
  19. University of Texas Health System (Austin) — 551
  20. LifePoint Health (Brentwood, Tenn.) — 544
  21. Mount Sinai Health System (New York City) — 535
  22. Cleveland Clinic Health System — 525
  23. Indiana University Health (Indianapolis) — 492
  24. Novant Health (Winston-Salem, N.C.) — 492
  25. Advocate Health Care (Downers Grove, Ill.) — 483

 

Source: SK&A’s report, 2016

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Clinical Trials Program Manager / Project Manager

Posted on August 5, 2016 | Categories: Clinical Trials | Posted by: admin

Clinical Trials Program Manager / Project Manager

 

Why Clinical Trials?

 

  • Clinical Trials are essential & scientific method for Developing & Delivering effective and safe a. Drugs, b. Medical Devices and c. Surgery
  • Most definitive method to determine whether a treatment is effective without biases
  • One cannot determine in an uncontrolled setting whether an intervention has made a difference in the outcome
  • Help determine incidence of side effects and complications

 

Types & Phases of Clinical Trials

 

  • Randomized or Non-Randomized Clinical Trials
  • Single-Center or Multi-Center Clinical Trials
  • Pre-Clinical Research, Clinical Studies, FDA Review & Approval, Go-to-Market Strategies and Post Market Surveillance
  • Phase 0, I, II, III, IV of Clinical Trials
  • Clinical Trials for Medical Device (CTMD)
  • Clinical Trials for Drug (CTD)
  • Clinical Trials for Surgery (STG)
  • Single Blind Clinical Trail (SBCT): A clinical trial where the participant does not know the identity of the treatment received
  • Double Blind Clinical Trial (DBCT): A clinical trial in which neither the patient nor the treating investigators know the identity of the treatment being administered

 

Phase 0 of Clinical Trials (Very Small Group: 10-15 Participants)

 

  • Phase 0 trials are the first-in-human trials
  • Preliminary data reveals what Drugs / Device interaction do to the body and to confirm per plan

 

Phase I of Clinical Trials (Small Group: 20 – 80 Participants)

 

  • To determine an acceptable range of doses and schedules for a new drug
  • Usually seeking maximum tolerated dose (MTD)
  • Participants often those that have failed other treatments
  • Phase I Designs based largely on tradition

 

Phase II of Clinical Trails (Large Group: 100 – 300 Participants)

 

  • To determine if new drug has any beneficial activity and thus worthy of further testing / investment of resources.
  • Doses and schedules may not be optimum
  • Begin to focus on population for whom this drug will likely show favorable effect
  • Phase II Designs are Screen Test using MTD from Phase I and evaluation of Toxicity

 

Phase III of Clinical Trials (Very Large Group: 1000 – 3000 Participants)

 

  • To compare experimental or new therapies with standard therapy or competitive therapies.
  • Very large, expensive studies
  • Required by FDA for drug approval usually followed by Phase IV trials to follow-up on long-range adverse events
  • Phase III Trial Designs is for the Controlled Experiments – Randomized Control Trial (RCT) is the gold standard to avoid several sources of bias & comparison
  • Goals of Phase III Clinical Trials is the determine if it is less expensive, less toxic and less invasive vis-à-vis existing drugs, Medical Device or Surgery

 

Phase IV of Clinical Trials

  • Post Marketing studies including the treatment’s risks, benefits, and optimal use

 

Clinical Study Design

  • Phase 2 & 3 drug trials are mostly designed as randomized, double-blind, and placebo-controlled

 

Role of CROs

 

  • Clinical trials are usually administered by a contract research organization (CRO) hired by the sponsoring company who generally provides the drug and medical oversight

 

Challenges of Clinical Trials

 

  • Some patients may not adhere to treatment protocol so it may dilute whatever true treatment effect exists
  • Patient Drop-out

 

Clinical Trials – Tools & Technology

 

  • CDMS Types – Paper based or Electronic. Usually Double Data Entry strategy is followed
  • Clinical Data Management System (CDMS) – to manage the data of a Clinical Trial / Research
  • Clinical Trial Management Systems (CTMS) viz. Allegro CTMS, ClinPlus etc.
  • Clinical Trials Data Format – XML, TXT, CSV, Matlab files or System Specific Files
  • Electronic Data Capture (EDC) – via Cloud, Web & Portal
  • Electronic Trial Master Files (eTMF) viz. Veeva, SureClinical etc.

 

Clinical Trials for Medical Devices

 

  • PMA – Pre Market Approval Application
  • Medical Device Classes – I, II, III
  • Stages for PMA device – Pre IDE on Animal Testing, IDE (Investigational Device Exemption) on Human Testing (Clinical Trial), PMA

 

Clinical Trials Project Manager – Roles & Responsibilities

 

  • As Clinical Trial PM, managed and delivered project plan, project status reports that include project actions / risks / issues, costs, budget, SOW, meeting minutes, etc.
  • Assist with various project activities, supporting project initiation, budgeting, planning, execution and completion, which may include project schedules, process development and budgets, tracking, status reporting, project communication, information gathering, coordination and facilitation of meetings, tracking and resolution of issues, and tracking risks and resources
  • Coordinate with Trial Sites, CRO’s, Consultants, Stakeholders, Principal investigators and other partners
  • Deep background into HealthCare including IT & Clinical Trials that are essential & scientific method for Developing & Delivering effective and safe a. Drugs, b. Medical Devices and c. Surgery
  • Experience with eTMF (electronic Trial Master File), Content Management System (CMS) implementations
  • Has built a IT & Project Management Framework on Clinical Trials for Medical Device and Drug covering Phase I, II, III or IV with help of Inspection Ready Documentation (IRD), Electronic Trial Master File (eTMF), CROs
  • Lead projects to assess organizational needs, capacity management practices, identifies gaps, and proposes new processes and tools to improve planning
  • Lead role in creation, execution and monitoring of complex documents, project plans, timelines, and coordination of review meetings
  • Management & Documentation of Surrogates used as alternative to desired or ideal clinical response to save time and/or resources
  • Plan and coordinate timely review, revision and approval of clinical documents
  • Possess excellent people and interpersonal skills. Contribute to process improvements related to creation and maintenance of clinical documentation
  • Possess excellent writing and communication skills
  • Proficient with MS Project (MSP) and other project management related tools
  • Proficient with Office, Microsoft SharePoint and Microsoft Vizio
  • Research and ensure compliance with applicable regulatory guidance and departmental SOPs
  • Responsible for the generation & management of clinical regulatory documents viz. briefing documents, Investigator’s Brochures, clinical protocols and amendments, clinical study reports, scientific manuscripts and abstracts
  • Very good understanding of the clinical research and associated regulatory, processes and quality requirements
  • Work seamlessly with CT Leadership, CRO – external partner / vendor

 

Contact Manish for Clinical PM role at 646.644.3049 or manish@techcusp.com

 

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HealthCare IT – Director of Enterprise Architecture & Business Analysis

Posted on July 29, 2016 | Categories: Business Analyst, Solutions Architect | Posted by: admin

HealthCare IT – Director of Enterprise Architecture & Business Analysis

 

  • Ability to provide Business Solution Architecture that fits within the Agile / Waterfall methodology
  • Ability to quickly and effectively understanding business issues and challenges
  • Ability to work with product managers and/or project sponsors to document the business vision and the project scope
  • Contributing to a consolidated business and technology roadmap (ensuring that resources, interdependencies and business priorities are effectively aligned)
  • Eliciting business needs and assisting in the refinement of business requirements
  • Engaging with business and IT groups to align solution architecture with strategic business direction
  • Experience in gathering and documenting detailed functional requirements using UML (Unified Modeling Language) T techniques (viz. use case preparation etc.) for software engineering or to analyze, design, and implement software-based systems along with other business processes for HealthCare domain.
  • Good knowledge in Cerner (formerly Siemens) Invision & Invision Registration and Billing (RCM) products
  • Helping to define the set of concepts, processes, and services that comprise the enterprise’s value chain and operations
  • Helps Technical Analysts with Application maintenance and support i.e. L1-L2-L3 set-up
  • Lead Business Analyst with at least 8 years of experience on US Healthcare Provider Platforms.
  • Providing informal mentoring to other members of the solution architecture team
  • Staying engaged throughout the entire project lifecycle to ensure ongoing alignment to solution architecture
  • Strong analytical skills, exceptional verbal and written communication skills, and a strong client-facing presence
  • The Director Accountable for aligning strategic goals and objectives with decisions regarding products and services; partners and suppliers; organization; capabilities and key business and IT initiatives
  • The IT Business Solution Architect plays a key role in structuring the enterprise in terms of its processes, capabilities and information
  • The primary responsibility is translating business goals and objectives into detailed business capabilities through the use of process flow diagrams, future-state operational changes and technical solutions
  • Thought Leader to product portfolio to improve competitive position and/or optimal product performance
  • Translating requirements into solution diagrams and other artifacts. Presenting artifacts to IT delivery teams to assist with the estimation and systems design process
  • Working with business and technology leaders to understand current and future-state process flows

 

Contact Manish for HealthCare Business Analyst or Solutions Consultant at 646.644.3049 or manish@techcusp.com

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Principal Consultant & Delivery Manager – HealthCare (Payers & Providers)

Posted on July 29, 2016 | Categories: ACOs, Analytics, Apps, Big Data, Care Management, Claims, Clinical Services, Clinical Trials, Consulting, Data Analytics, Health Exchange, Health Insurance, HealthCare | Posted by: admin

Principal Consultant & Delivery Manager – HealthCare (Payers & Providers)

 

  • The Principal Consultant & Delivery Manager (PCDM) leverages combined people, process, analytics and technology competencies to support large-scale, complex customer engagements
  • The Principal Consultant & Delivery Manager (PCDM) is responsible for driving customer value through client facing advisory and delivery services. A subject matter expert and trusted advisor for Payers, Providers, Clients & Program Management Team and works closely with engagement and technology team to define strategic and tactical direction
  • Collaborates with Leadership, Product, Infrastructure &Security teams to configure solutions and deliver value to customers. Responsible for identifying and solving business / systems issues
  • Contribute to the delivery and execution of complex, large scale, multi-year (high cost, high complexity and/or high risk) client enterprise transformation programs
  • Deliverables include leading major work streams and projects, supporting pre-sales and sales activities, owning deliverables, building key customer relationships, building and sharing institutional knowledge, and developing junior professionals
  • Build, share, and maintain expertise in both practice area and client environment, regularly interface with Product, Infrastructure, and Security teams to deliver on customer commitments
  • Contribute to operational readiness, organizational change management, solution capability, packaging, and estimating, planning and delivery management
  • Contribute to pre-sales and sales activities for revenue growth
  • Lead major engagement work streams and projects to meet milestones on time, and to deliver with high quality and within agreed to budgets
  • Plan, organize, staff, direct and control the operations of the department; develop and implement policies and programs as necessary; may have budgetary responsibility and authority
  • Use Data Analytics & information sets for analysis, creating hypotheses and presenting recommendations to team; developing client specific requirements, standard operating procedures (SOP), functional roles & responsibilities, process flow and user guide per SOW

 

Contact Manish for Sr HealthCare Consultant @ 646.644.3049 or manish@techcusp.com

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