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Category Archives: Clinical Trials

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

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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


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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

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Data & Analytics in HealthCare

Posted on July 26, 2016 | Categories: Big Data, Claims, Clinical Trials, CMS, Data Analytics, Data Mining, Data Scientist, Database | Posted by: admin

Data & Analytics in HealthCare


Data & Analytics Adoption Model in HealthCare for Access, Cost, Quality (ACQ)

  • Three stages of data management via EDW – 1) data collection 2) data sharing / access and 3) data analytics
  • Bulk of Data Collection are done via electronic health records (EMR/EHR) and health information exchanges (HIE/HIX)
  • Data & Analytics is playing a big role in Health System Quality improvement and cost reduction efforts
  • Healthcare Analytics Adoption Model borrows & leverage recommendations from HIMSS EMR Model, Health & Human Services (HHS), Food & Drugs Administration (FDA rules for Clinical Trials) and Center for Medicare & Medicaid (CMS)
  • The Adoption Model may include – evaluating the industry’s adoption of analytics, roadmap for measure progress toward analytics adoption and evaluating vendor products for improving the quality of care while lowering costs and enhancing clinician and patient satisfaction


8 Stages of the Data & Analytics Adoption Model

  • Adoption Stage 1 – Enterprise Data Warehouse (EDW) using Physical or Virtual Servers
  • Adoption Stage 2 – Registration & Billing System including Patient Registries via Personal Portal
  • Adoption Stage 3 – Electronic Health Record &Electronic Prescription System (EMR & eRX) for clinical observations and lab results
  • Adoption Stage 4 – Management & Internal Reporting Tool / Dashboard
  • Adoption Stage 5 – Statutory& External Reporting Tool / Dashboard i.e. Meaningful Use Reporting
  • Adoption Stage 6 – Fraud & Abuse reduction using Claims Data
  • Adoption Stage 7 – Population Health Management (PHM) & Care Management Analytics
  • Adoption Stage 8 – Predictive Analytics (PA) leveraging PHM, CM, UM Data for Preventive Care to Cost Curve and Patient Care / Patient Satisfaction


Top use cases for data and analytics for Health IT organization

  • Adoption Analytics – Clinical Workflows & Applications
  • Claims Analytics – Fraud & Abuse
  • Cost Analytics – Planning & Control
  • Customer insight Analytics – Customer Care
  • Discovery/search Analytics – Clinical Trials
  • Meaningful Use Analytics – Positive Outcome
  • Operations Analytics – Customer Service
  • Predictive Analytics – Bend the Cost Curve
  • Risk and Compliance Analytics – PHI & HIPAA


How much data and analytics contribute to Health organization’s decision?

  • Differentiate
  • See the future
  • Drive revenue growth or Bend the Cost Curve
  • Clinical Workflows & Software Applications
  • Customer Care
  • Fraud & Abuse
  • Guide future strategy
  • PHI & HIPAA Compliance
  • Planning & Control
  • Product research and development
  • Product research and development – Clinical Trials for Drugs discovery & approval for medical equipment by FDA
  • Sales/Marketing


Challenges in Health organization in adopting data and analytics strategy

  • Budget & Priority
  • Information Explosion
  • Inoperability of Data
  • Managing Data Vs Analyzing Data
  • PHI / HIPAA Challenge
  • Quality of Data – Data duplication or Data Integrity
  • Varied Application System within Health System


Metrics or benefits /business outcomes for data and analytics in HealthCare

  • Cost Curve
  • Ethical intent
  • Go-to-Market for Drugs
  • Interoperability
  • Legal compliance for PHI (Privacy) & HIPAA
  • Population Health Management (PHM)
  • Transparency


Proof of Data & Analytics working for Health Organization

  • A code of ethics around data and analytics
  • C-level support
  • Claims Dashboard
  • HEDIS STAR Rating
  • Meaningful Use Metrics
  • Pain Management Dashboard
  • Prescription Dashboard for Controlled Substances
  • Tracking customer views
  • Transparency on what customer data is being used





Sr Project Manager – Clinical Trials and eProjects

Posted on July 20, 2016 | Categories: Clinical Trials, HealthCare, HealthCare IT | Posted by: admin

Sr Project Manager – Clinical Trials and eProjects


(Clinical Trials eTMF Portal) – Development & management of Clinical Trials via eTMF Portal

  • Implementation of an Electronic Trial Master Files (eTMF) Cloud Based Portal to seamlessly & real-time park & retrieve Clinical Trial Data & Clinical Trial Documents by Sponsors, Sites, Regulators and Participants (SSRP). This tool helps reduce Clinical Trial Time (CTT) and enhances Inspection Readiness & Re-Usability (IRR)
  • The Portal supports FDA approved protocol for electronic records, digital media and digital signatures
  • Managed connectivity of 8 Site to the Azure eTMF Portal via Secured Messaging, Content Management System (CMS) & Microsoft SharePoint

The Senior Project Manager – Clinical is responsible for managing the performance and functions of assigned projects – planning, reviewing and controlling the activities and conduct of project team members and/or team leaders for multiple project teams charged with the analysis, requirements definition, selection, implementation and review of major information technology systems.

  • Confers with hardware and software vendors providing programming and analysis services.
  • Contacts vendors regarding systems issues to receive support information or assistance. Negotiates software fix delivery dates in order to maintain progress within defined project timelines and budgets.
  • Creates and maintains a teamwork environment conducive to productive output, successful project delivery and ultimately meeting organizational goals associated with major efforts.
  • Demonstrates strong interpersonal skills, possesses good negotiating skills and promotes teamwork among IT, user, vendors and consultant team members.
  • Developing technical project plans, budgets, and technical specifications.
  • Develops and implements effective written mechanisms to document and report on all plans, priorities, schedules and the current status of all projects.
  • Develops, plans and manages detailed project budgets, tracking all capital and operational expenditures and regularly reporting the budgetary status of all assigned project budgets including hardware, software and support components.
  • Establishes and monitors project quality objectives, milestones and benchmarks. Develops and implements effective tools to measure performance against these standards, and to document and regularly report on all plans, priorities, schedules, budgets, team assignments, and the current status of assigned projects.
  • Industry work experience in healthcare such as hospital, managed or long-term care, insurance, government or other healthcare agency.
  • Interfaces with and supports staff in all areas and at all levels in the definition of requirements, selection, design, development, and implementation, of information systems.
  • Knowledge and/or experience in managing cross-functional projects that yielded meaningful results.
  • Knowledge and/or experience in managing or working on projects across multiple departments using an SDLC methodology and Waterfall or Agile/Scrum methodology. Hands-on experience with multiple Agile techniques: User Stories, Continuous Integration, Continuous Testing and  Automated Testing.
  • Knowledge and/or experience in using an enterprise project management system such as MS Project Server and MS Project.
  • Knowledge and/or experience with application and/or systems implementations or upgrades.
  • Knowledgeable of Regulations from Food & Drugs Admin (FDA), Department of Health (DOH) and Center for Medicare & Medicaid Services (CMS)
  • Maintains follow-up process for system deficiencies and issues reports. Analyzes and recommends procedural standards and changes to enhance user tasks and correct problem areas, as they become known, prior to systems go-live.
  • Plans, prioritizes, manages and schedules of large, complex projects, often overseeing multiple efforts and coordinating activities of other project managers.
  • Provides assistance in the management of contracts and budgets for projects that may involve multi-million dollar agreements
  • Provides effective oral and written communications to staff to facilitate understanding, ownership and accomplishment of project goals and objectives.
  • Provides ongoing leadership and motivation to ensure that the project teams are focused, committed and capable of producing expected results.
  • Responsible for pre-implementation analysis and process re-design affecting the business and care processes to support organizational operations, and for measuring the effectiveness of, and recommending post-implementation strategies for enhancing the usefulness of all assigned computer system application programs, technologies and systems required to support the needs of the organization.
  • System Architectural Planning: Insuring engineering, architecture, and design of technology infrastructure to support software products.
  • System Integration Planning: Designs plans for interfacing and integrating various software packages as necessary.
  • Technical Analysis Design, and Development and Software Quality Assurance: Supports implementation of software applications. Provides oversight in the design and development of software applications, interfaces and custom programming, and testing processes through definition of test plans, test review and analysis, end-to-end system integration testing, and certification of software. Familiar with standard testing concepts, practices, and procedures.


Contact – Manish Jaiswal, 646.644.3049.

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