Ensuring Efficiency and Speed with Practical Solutions for Clinical Operations

Clinical operations professionals encounter unique challenges. Balancing regulatory requirements, tight timelines, and the need for cross-functional collaboration can create significant internal pressures. Our upcoming webinar will introduce key strategies and tools to streamline and enhance clinical development processes, helping you overcome these challenges.

1. Ensuring Efficiency and Speed with Practical Solutions for Clinical Operations Innovate, Adapt & Deliver

2. Biotech/Pharma Customers Who Is Robert Happy, Managing Director, Biotech-Pharma PMP, MCTS, MCT ? [email protected] call, text, email anytime [phone] Over 25+ yrs in project & portfolio management consulting and training experience in Biotech-Pharma Published book, multiple articles and training programs on PM and Project Tools Worked with 100’s of organizations and 1000’s of individuals to optimize PPM PMP certified and senior level consultant/advisor Managing Director of OnePlan, Biotech/Pharma Practice Implemented multiple GPMs/PMO’s, processes, systems from large to small start-up Biotech-Pharma while working with all the main functions from Early Research/Discovery, Nonclin , CMC, Clinical, Regulatory, Commercial

3. - Global PPM Leader for 5 Consecutive Years Consistently Recognized as a Market Leader OnePlan cited as a top vendor in “Determine the Future of Microsoft Project in Your Organization” Strategy and Innovation 2023 Peer Insights “Voice of the Customer” Strategic Portfolio Management

4. Key Challenges Facing BioPharma Clinical Operations Along with the ongoing challenges for managing clinical operations such as study design/approvals, patient recruitment/retention, dealing with complex regulations, drug supply/supply chain and data management – OnePlan (Strategy, Project, Program & Portfolio Management Platform) can optimize performance and address the following challenges to name only a few key areas: Operational Efficiency – managing complex clinical programs with feasible timelines, budgets and resources for various study designs with multiple sites. Help ensure efficiency and speed across your portfolio. Stakeholder Management – clear communication and coordination across all parties involved for both internal (CMC, Reg, Nonclin ) and external stakeholders (CROs, sponsors, regulatory bodies, and clinical sites). Ensure all stakeholders are working on prioritized mission critical activities. Financial/Budget & Resource Management - Clinical trials are expensive and managing budgets & resources effectively to avoid overruns is critical. Optimizing the allocation of resources and funds to maximize efficiency. Technology Integration – consolidating clinical program related information in one place for quick and easy access to real time information to optimize alignment of strategic goals and execution. One point of entry, one source of truth. Visual Meaningful Consistent and Reliable Information - served up in the way you need it to align on mission critical activities and drive timely key decisions with meaningful visualizations & dashboards backed by the ‘right-sized’ detail to give you peace of mind.

5. PROJECT & PORTFOLIO MANAGEMENT FOR CLINICAL DEVELOPMENT PROGRAMS, LEADERSHIP & TEAMS Corporate & Quarterly Goals Portfolios (Assets/Molecules - Development, Commercial, Marketed) Franchise/Therapeutic/Disease Areas Indication – Products/Programs Discovery Phase 1 Phase 2 Phase 3 Submission Launch Optimize Resource Utilization, Communication Across Clinical Programs & Teams We specialize in ‘right sizing’ Tools to Maximize your ROI By Dev Stage, Region, Therapeutic Area, Asset/Indication and/or Functional Team for effective communication and optimize time to submission & launch Associate and align – one point of entry, one source of truth – drive alignment on meeting goals Aggregate and rollup to facilitate better decision-making Variety of tools right sized to meet your exact needs Translate to common dashboards and visualizations Clinical Operations

6. Demonstration Flow Part 1 - Clinical Ops/Dev Plans All in One Place Consistently & Reliably Part 2 – View the Holistic Picture with Meaningful Views Tailored To Your Exact Needs Part 3 – Prioritize & Select the Right Clin Programs while Balancing Resources and/or Costs to Maximize Benefits Part 4 – Align Teams & Programs with Goals, Objectives & Key Results (OKR’s) Part 5 – Execute & Deliver Results with Team Collaboration Focused on What Matters Most

7. Part 1 - Clinical Ops/Dev Plans All in One Place Consistently & Reliably Use consistent tools, templates, metrics and terminology Create one source of truth and preferably one point of entry Align stakeholders up and down and across the org with no surprises Flexibility and scalability with tools with real time access Highly secure cloud based with flexible permissions

8. Use Consistent Template Library to Efficiently Build Clinical Development Plans with Built In Metrics & Terminology Use standard set of templates for various clinical ops plans, studies, and scenarios Drive consistent terminology, process and metrics.

9. Manage Clinical Plans at Any Level of Detail Across Indications Manage clinical timelines directly in OnePlan, Smartsheet, Microsoft Project (Desktop Pro or For the Web) and option to experience it via MS Teams. Track all your GRAIDL (Goals, Risks, Actions, Issues, Decisions, Lessons Learned) all in one place. Also program metadata (details), financials and resource plans – all highly configurable to meet your exact needs. Note: Views, Lists, Fields, Layouts – all highly configurable

10. Software Development Ideation Professional Services Financial Management Work Management Service Management Private Cloud Connector Use Integrators to Capture All Clin Ops Info In One Place Dynamics 365 Dynamics 365 Dynamics 365 Strategy Enterprise Architecture Viva Goals Data / field mapping Business rules Workflows Scheduling Logging Extensible and Flexible Let’s Take A Look

11. Part 2 – View the Holistic Picture with Meaningful Views Tailored To Your Exact Needs View portfolio of clinical dev plans by stage, therapeutic area, asset, region and so on View the information that is important to you in the way you need Easily drill up or down as needed from the high-level big picture down to the ground level Various views for various stakeholder needs – easily tailor to your audience

12. Use Interactive Automated Dashboards to Align & Optimize View portfolio of clinical dev plans by stage, therapeutic area, asset, region and so on View the information that is important to you in the way you need Easily drill up or down as needed from the high-level big picture down to the ground level Various views for various stakeholder needs – easily tailor to your audience Let’s Take A Look

13. Part 3 – Prioritize & Select the Right Clin Programs while Balancing Resources and/or Costs to Maximize Benefits Prioritize clin plans based on key business drivers & goals Scenario planning & modeling Plan and model based on resource capacity and future needs Plan and model based on financial goals and targets Visualize results & make decisions

14. Use OnePlan’s AI Engine (Sofia) to Help Drive Decisions and Get Information Fast

15. Use the Modeler to Balance Resources

16. Use the Modeler to Balance Finances

17. Use Resource Plan Heat Map to View & Balance Resources Use the Match and Replace Function to Manage Over or Under Allocations

18. Use Master-Sub Plans to View Across Multiple Clin Programs Load plans across programs to optimize scenarios & timelines at a more granular level Let’s Take A Look

19. Part 4 – Align Teams & Programs with Goals, Objectives & Key Results (OKR’s) Manage and track organizational goals and/or objective & key results (OKRs) Align goals & objectives to programs, projects, tasks Ensure teams are working on mission critical objectives Utilize meaningful visualizations to optimize performance

20. Associate Goals to Projects & View Interactive Dashboards You can associate goals with programs/projects and team members and track status as needed. Let’s Take A Look

21. Part 5 – Execute & Deliver Results with Team Collaboration Focused on What Matters Most From SLTs/ELTs to team members, ensure everyone is working on mission critical activities Collaborate across the organization from strategic decision making to daily workload/task management Tailor meaningful and usable views & information for each stakeholder Balance the the tools and information needs to just right (not too much and not too little) to optimize performance

22. Team Members Aligned at the Ground Level All work aligned with strategic goals & programs = mission critical tasks Use our OnePlan app to easily manage on your mobile device/phone.

23. Manage RAIDL+ Items/Logs the Way You Need To Out of the Box or Configure You Way: Changes, Goals, Risks, Actions, Assumptions, Issues, Decisions, Lessons Learned, Agenda Items. Add new list logs or delete to simplify – whatever you need all in one place.

24. Experience OnePlan Integrated with Teams and/or SharePoint Use OnePlan directly in Teams or Integrate with SharePoint for Document Management Let’s Take A Look

25. For more information: [email protected] [email protected] Free Offers and Next Steps FREE – BioPharma OnePlan Trial FREE – Roadmap Workshop FREE – Personalized 1:1 Demo www.oneplan.ai oneplan.ai/biotech-pharma-solution

26. Contact Us [email protected] www.oneplan.ai Robert Happy [email protected] Thank You!! The Power of One