V37 N1 / 2022 ©2022 American Medical Writers Association. All rights reserved. ISSN 2163-5315 AMWAJournal.org 38 ABSTRACT This article will discuss the real-world application of agile project strategies to expedite the development of high-quality deliverables that satisfy the structure and rigor of the regula- tory environment. The coronavirus disease 2019 (COVID-19) pandemic challenged regulatory writers not just to rethink the structure of their workdays and the nature of their inter- actions with their colleagues but to leverage technology and adopt strategic project thinking to help their teams meet aggressive timelines while working in the virtual workspace. Scenarios will include the application of agile project strate- gies to working on COVID-19 programs or programs heavily impacted by COVID-19, from expedited submission pro- cesses to rapid responses to regulatory authority requests for information. This assessment will include what strategies worked well, what strategies did not, and what an agile proj- ect should look like within the regulatory writing space. Across industries, different methodologies for project man- agement are used. The most popular include the waterfall, Kanban, adaptive project framework, lean, and critical path methodologies.1 The reason for the variety in project man- agement styles is simple—optimal delivery of a product in any industry requires processing of multiple intrinsic and extrinsic variables. In our experience in the biotech and pharmaceutical space, most regulatory writing deliverables have been planned by using the waterfall methodology; but the current space has become more dynamic, influenced almost daily by decisions made by regulators, research com- mittees, health care professionals, venture capitalists, and— most importantly—the scientific method itself. Delivering quality regulatory documents in the current space requires methodology adaptation to an evolving landscape. As the discipline of project management in other industries has evolved to account for ever-increasing change, with proj- ect lifecycles now ranging from the very plan-driven to the iterative to the highly adaptive,1 the authors considered whether non-waterfall methodologies could be adapted to regulatory writing. This article briefly describes the waterfall approach his- torically used in medical writing and discusses the appli- cation of alternative project management methodologies to achieve quick, adaptive, and controlled regulatory docu- ment development. THE WATERFALL APPROACH AND ITS PITFALLS Regulatory writing project management typically has fol- lowed the waterfall method, which aligns with document development in an environment requiring sponsors to implement and maintain quality systems. The standard operating procedures (SOPs) that underpin these systems are often prescriptive, delineating steps that can be docu- mented, thereby demonstrating compliance. Project time- lines tend to mirror these SOPs in their fixed, stepwise progression toward controlled content creation. Project management software uses predecessor/successor inputs to capture this progression and can leverage this infor- mation to generate understandable outputs for coauthors and non–medical writing stakeholders. The benefits of the methodology include ample time for both the regulatory writer and coauthors to think, research, and then write and align reviewer comments and changes across the document before the next iteration. This project management methodology is ideal for proj- ects with a predictable path.1 The format and content of nonpivotal clinical study reports (CSRs), annual investigator brochure updates, or developmental safety update reports (DSURs) are well described in the regulations, generally limiting stakeholder impact on document structure, and the timelines may be defined by regulation (eg, DSURs) or may be driven by fewer extrinsic factors (eg, a competitive landscape). Whereas the waterfall methodology relies on predict- ability, the regulatory writing environment has changed dramatically since the pandemic began. Regulations regard- ing coronavirus disease 2019 (COVID-19) and non–COVID- 19 studies, contract research organization (CRO) and site procedures, and sponsor priorities shifted to enable accel- Jeanette M. Towles and Jason S. Casavant / Synterex Inc, Boston, MA Agile Strategies in the Rigid Regulatory Environment RESEARCH http://www.amwajournal.org AMWAJournal.org 39Agile Strategies in the Rigid Regulatory Environment erated clinical evaluation of diagnostic, therapeutic, and preventive products to address the pandemic. Regulatory writing projects have been initiated without an assessment of requirements (eg, initiation of a full protocol without iden- tified study endpoints due to an evolving understanding of the clinical course of the disease), well-vetted concepts, or access to real-time investigator clinical observations.2 Consequently, regulatory writers have been asked to coau- thor in real time in a manner significantly divergent from the stepwise collaboration afforded by the traditional waterfall methodology. ALTERNATIVE PROJECT MANAGEMENT STRATEGIES During the first half of 2021, our operational and executive teams reviewed opportunities for continuous improvement. We focused on several COVID-19–related regulatory writ- ing projects because of a recent uptick in requests for sup- porting projects with accelerated timelines and imperfectly defined parameters similar to what we had observed with COVID-19–related projects, leading us to wonder if a linear way of working might become a relic and if we might need to adapt all or part of our business model. The scenarios we selected for review included the following elements: • Required multiple resources within the company (eg, regulatory writer and operations support). • Required >50% resource utilization for the regulatory writer for a discrete period. • Timelines did not follow a sequential pattern (ie, one or more authoring steps were concurrent), so the writer was unavailable for other projects. • Coauthoring with the client was done by using collab- orative technology. The selected projects had a timeline that was prospec- tively created and/or maintained by the regulatory writer and that was available for resourcing manager review. Scenario 1 At the time of project initiation, just shortly before the pan- demic was declared, one could count on both hands the number of COVID-19–related studies in clinicaltrials.gov. The regulatory writer used relevant soft- ware and searches of clinicaltrials.gov for recruiting COVID- 19 treatment studies to collect clinical intelligence and develop a protocol synopsis, which was then used to facili- tate regulatory agency, CRO, and site interactions (Table 1). After receipt of Food and Drug Administration (FDA) feed- back on the pre–investigational new drug application (IND) package and about 2 weeks before IND submission, the FDA issued guidance on COVID-19–related study con- duct.3-5 Given that the protocol was nearly finalized, the team had to quickly interpret the guidance, implement any changes addressing conflicts with prior clinical intelli- gence and an evolving standard of care, and confirm those changes with internal and external stakeholders (eg, con- firm that the FDA’s oxygenation cutoff for disease severity matched the site’s cutoff). Traditional stepwise project management methodol- ogies were recognized as being too rigid for this dynamic environment, so the team incorporated strategies used in more adaptive methodologies. Change was rapidly com- municated through a phone tree and scheduled check-ins every other day, with ad hoc meetings called for specific topics or live edits. The core authoring team was limited to the regulatory writer, clinician, and clinical trial manager, Table 1. Scenario 1: Medium-Sized Pharmaceutical Company Filing an IND in a COVID-19–Related Indication Type of Product Treatment (COVID-19) Requirements File IND Systems Teams, PleaseReview (sponsor owned) Regulatory Writing Resources External consultants (no established MW department) Timelines Pre-IND meeting request package 3 weeks IND (2 weeks from pre-IND feedback) Stakeholders US regulators; later in the process, global regulators IRB/IEC Internal team Internal management Study sites External philanthropy groups (funding) CRO Regulatory Landscape Guidance still being drafted, no guidance available on endpoints and objectives yet; heavy cross-referencing to an existing IND in another indication Risks Proceeded with protocol and informed consent form writing at risk ahead of pre- IND feedback to meet timelines; defer many of the details on testing and analysis to ancillary documents (eg, Pharmacy Manual) because details not available yet (EUA for diagnostics had occurred only a few weeks previously2) Project Management Strategies Communication phone tree Stand-up meetings every other day between work sprints Resource layering for ancillary writing tasks Small core team Cloud-based authoring and review COVID-19, coronavirus disease 2019; CRO, contract research organization; EUA, emergency use authorization; IEC, independent ethics committee; IND, investigation- al new drug application; IRB, institutional review board; MW, medical writing. http://www.amwajournal.org http://clinicaltrials.gov http://clinicaltrials.gov AMWAJournal.org 40Agile Strategies in the Rigid Regulatory Environment with supplemental members reviewing specific language in the protocol, which enabled efficient and focused authoring during short work sprints. All authoring was done in Teams, with access managed by a dedicated information technol- ogy (IT) professional who was part of the phone tree. A reg- ulatory writing operations associate supported the writer by formatting, locating references, and managing citations. The document underwent a single round of management review in PleaseReview, during which most of the reviewers used the software’s commenting feature to provide substantive feedback. The team vetted management comments together, and the core authors discussed any outstanding issues with their line management outside of the review and reported back the results of the conversation. Roundtables attended by all core and supplemental authors as well as the manage- ment reviewers were used to efficiently align on resolution of any pending comments. Structured communication and cloud-based tools were leveraged by the small core team, enabling them to effi- ciently respond to shifts in the regulatory landscape while also permitting team members to author, consult with management and subject matter experts, and achieve con- sensus. The team successfully provided a quality deliver- able during an uncertain time in drug development and advanced an important potential treatment for COVID-19. Scenario 2 This project proceeded in the context of hyper-compressed timelines and the need to look at not only new interim data but also cumulative data (Table 2). While the CRO was pulling the marketing application documents together and facilitating the various reviews, full-time employees (FTEs) and consultants provided over- sight and management of timelines and risks and facilitated interactions with multiple internal and external stakehold- ers. Because of the time constraints on the project, live data reviews were employed, during which the CRO regula- tory writer engaged directly with stakeholders early in the drafting process, allowing for real-time drafting, consensus building, and a reduction in draft cycles. The success of this approach was contingent upon the availability of the correct attendees and their endorsement of this adaptation over more traditional iterative authoring and review processes. Although Scenario 1 used a small core team with tar- geted reviewers to achieve consensus, this scenario used a larger review team, which included team members and management, to increase functional alignment at approval, which worked in large part because of the team trust at all levels. In this scenario, the use of PleaseReview followed highly prescriptive SOPs that did not enable the internal reg- ulatory writers and the consultants (who only had reviewer licenses) to review live copies of fundamentally relevant documents (eg, parallel review of in-development CSRs or summary modules and in-development clinical overview). The system was used for a stepwise review, comment rec- onciliation, and closeout workflow. Although PleaseReview allows for the attachment of reference documents to the review, those documents were changing concurrently, ren- dering this option ineffective. Ultimately, a system was needed to facilitate document finalization with the key sub- ject matter experts after team review. An initial attempt to use SharePoint for this activity failed because of a lack of prospective access management as well as restrictions on the use of guest accounts (for external consultants and reg- ulatory writers) for internal SharePoint sites; the writer and subject matter expert resolved outstanding issues via email. Table 2. Scenario 2: Medium-Sized Pharmaceutical Company Filing a Marketing Application in a COVID-19–Related Indication Type of Product Preventive (COVID-19) Requirements File a marketing application Systems Teams, PleaseReview (CRO owned), Veeva Regulatory Writing Resources CRO writers Internal FTE External consultants functioning as em- bedded FSP (established MW department) Timelines 12 weeks (changed to 8 weeks)—critical/ ASAP Stakeholders Global regulators, including multiple US bodies IRB/IEC Internal team Internal management Study sites CRO Regulatory Landscape Rapidly evolving; constant feedback from multiple agencies and the need to resolve divergent feedback; prior EUA and global conditional approvals Risks Competitive landscape is a significant concern Multiple overlapping documents to meet timeline Sponsor exponential growth in a short timeframe Project Management Strategies Communication phone tree Stand-up meetings every other day between work sprints Resource layering for ancillary writing tasks Small core team Cloud-based authoring and review ASAP, as soon as possible; COVID-19, coronavirus disease 2019; CRO, contract research organization; EUA, emergency use authorization; FSP, full-service provider; FTE, full-time employee; IEC, independent ethics committee; IRB, institutional review board; MW, medical writing; SME, subject matter expert. http://www.amwajournal.org AMWAJournal.org 41Agile Strategies in the Rigid Regulatory Environment As a lesson learned from other submissions on the same program and aligned with sprint-style project management methodologies, the regulatory writing team attended spe- cific key meetings, communicating about the submission and permitting the team more time to complete action items. The sponsor’s Head of Medical Writing attended gen- eral meetings and CRO meetings, and the external consul- tants divided up CRO meetings and other internal meetings; all external consultants and CRO writers attended most doc- ument roundtables and stand-up meetings. Those who did not attend could access meeting information via a Teams chat, email, or a OneNote summary. Overall, although there were observations for future pro- cess improvement, the regulatory and quality requirements of this dynamic submission were met, and a submission was filed on time for approval of a groundbreaking regulatory document. Scenario 3 The work for this early-phase protocol began as sites across the United States began restricting access because of infec- tious disease procedures.2 The protocol for this critical disease had been finalized around the same time the first COVID-19 cases were reported in the United States, and the study was in start-up (Table 3). As COVID-19 cases began to rise globally, the sponsor’s concerns mounted regarding the likely impact on study enrollment as well as the ability to ensure proper safety follow-up if patients were enrolled. A protocol amendment was planned to allow for alternate assessments and to reduce the overall travel burden and the chance for COVID-19 exposure for the patient, with the amendment including home collection of samples, select phone visits, alternative media for patient-reported out- comes and informed consent, and home nursing for safety assessments and drug accountability and dispensation (as a last resort due to high cost). Guidance from the FDA on the conduct of studies during COVID-19 was issued several weeks into protocol development and informed several key mitigations that were planned6; however, at the time the guidance was issued, the pandemic was evolving, and the agency determined that prior public participation for the guidance was not feasible or appropriate, so early guidance was open to some interpretation.7 The core authoring team was limited to the regulatory writer, regulatory writing operations associate, clinician, clinical trial manager, regulatory strategist, program man- ager, and drug supply/ Chemistry, Manufacturing, and Controls manager. Involvement of each function in this group assured that the protocol was updated efficiently and accurately as conversations progressed with the CRO and other vendors in daily, 1-hour, focused working meetings. Authoring was done in Teams, with access managed by an FTE on the core authoring team. The document under- went a single round of management review using the spon- sor-owned PleaseReview platform, with the regulatory writer initiating and managing the review. Similar to review- ers in Scenario 1, reviewers in this scenario mostly utilized the commenting feature. The team vetted management comments together, and the core authors gained align- ment with their line management outside of the review. All authors as well as the management reviewers attended the roundtables. By limiting the team to line-function representatives, employing regular meetings, and using authoring and review tools that promote transparency, the team effectively Table 3. Scenario 3: Medium-Sized Pharmaceutical Company Amending a Protocol in a Non–COVID-19 Indication During the COVID-19 Pandemic Type of Product Treatment (non–COVID-19) Requirements Team was tasked with finding a way to add necessary flexibility to the study due to the evolving COVID-19 closures in H1 2020 Systems Teams, PleaseReview (sponsor owned) Regulatory Writing Resources External consultants (no established MW department) Timelines 2 weeks Stakeholders Global regulators, including multiple US bodies IRB/IEC Internal team Internal management Study sites CRO Regulatory Landscape Guidance on the conduct of studies during COVID-19 newly issued; IND had been open for some time, with one other completed early-phase study Risks Q&A on FDA guidance on the conduct of studies during COVID-19 issued and updated during amendment authoring; implementation required active discussion with CRO partners and subcontracted vendors to ensure proper description and execution; mitigations might not be successful and came with a high price tag; small company with limited resources Project Management Strategies Resource layering for ancillary writing tasks Core authoring team representing each function Cloud-based authoring and review COVID-19, coronavirus disease 2019; CRO, contract research organization; FDA, Food and Drug Administration; H, half (of the year); IEC, independent ethics commit- tee; IND, investigational new drug application; IRB, institutional review board; MW, medical writing; Q&A, Questions & Answers. http://www.amwajournal.org AMWAJournal.org 42Agile Strategies in the Rigid Regulatory Environment used multiple minor draft sprints to implement information and gain consensus as it became available in between meet- ings with stakeholders and partners. The project aligned with emerging regulatory guidance while mitigating the impact of COVID-19 on enrollment, study feasibility, and participant safety. DISCUSSION Each regulatory writing project has a unique budget and unique collaborators, timelines, risks, and gaps. The regula- tory writer and regulatory project manager must discuss the linkages of a project with department and company goals and determine the project management principles to apply; gathering the project requirements should be a deliberate process even in the face of urgent issues or tight timelines. In consideration of the scenarios described in this article, we determined that the strategies that best balanced a controlled process with adaptability were derived from the agile project management method (Figure 1), par- ticularly the scrum framework. This method, often used in software development, is employed when the “require- ments,” or specifications the software needs to meet, change over time as a result of competitive intelligence or other factors; this method uses continuous planning to rapidly identify and implement change.8 In all 3 of our scenarios, microdrafts were produced in short bursts, or “sprints,” in between other milestones (eg, internal meetings, stake- holder meetings), continuously delivering a work product informed by feedback at all stages (Figure 2). Early and frequent delivery of microdrafts maintains project momentum and reduces the overall amount of work being done later in the process as well as the potential that late-breaking information could jeopardize quality or Figure 1. Principles of agile project management. Source: Rigby et al.8 Figure 2. Waterfall compared with Agile methodology for document production. Adapted with permission from Kissflow.10 . http://www.amwajournal.org AMWAJournal.org 43Agile Strategies in the Rigid Regulatory Environment on-time delivery. Regulatory writers often leverage relation- ships to deliver quality documents on time, but the commit- ment in these scenarios to produce high-quality microdrafts required the authoring team to be in regular contact to self-regulate and agree on the tasks to be completed, check on progress, and course correct as needed. The focus on optimal technical quality and design in this method is inherently aligned with the rigor required for regulatory documentation as well as the need to position regulatory documentation for the intended audience, and the meth- od’s approach to simplicity is also aligned with the latest “lean authoring” trends in regulatory writing.9 Any methodology must be paired with the best tools, systems, and practices. Setting expectations for how the team will work together and outlining roles and responsibil- ities, as well as scheduling regular checkpoints, were criti- cal success factors in each scenario. In addition, proactively managing systems access and education as well as the avail- ability of a dedicated IT business partner to triage technical issues led to a more efficient authoring experience in some of the scenarios, even in a remote environment. It is also worth noting that no system is perfect; informing reviewers of any system limitations may help avoid pitfalls (eg, spon- sor’s SharePoint is only set up to retain a certain number of versions, or contractors may not have compatible versions of Microsoft Office for coauthoring). Lastly, archiving com- ments and decisions produced within any system requires regulatory writer discipline and should follow best practices and sponsor procedures to ensure that the rigor of regula- tory documentation is met. Project management software was critical to the success of each of these projects, but we also concluded that certain software features not often used by regulatory writers have become critical in assessing the available resource pool. For example, we had underutilized the project utilization fea- ture to show the exact number of hours that a writer would be dedicated to a project within the start and stop dates for a task.11,12 As the pandemic progressed and project complexity increased, we implemented the software’s enterprise resourc- ing function, thereby enabling automatic initial notifications of project plan updates in between regular checkpoints. As a result of our analysis, we also invested in Power BI business intelligence software to visualize data from mul- tiple enterprise applications, including project manage- ment and customer relationship management software. Implementation of this analytical tool empowered our lead- ership team to efficiently track resource allocation and other details, including funds remaining on work orders at both the client and contractor level.13 Communication was paramount in the completion of each document in the scenarios. Although the teams came to different conclusions about meetings, they each decided proactively how often and how to interact. Setting such expectations up front in a project both increases the odds of the project’s technical success and manages the potential for over-accessibility and burnout. If the team cannot pull away from these digital tools because of an inundation of competing requests, they cannot get the work done. In one of these scenarios, the sponsor acknowledged that they his- torically had this exact issue and successfully addressed the feedback by dividing and conquering meeting attendance. Thus, several of the principles within the agile method, including the preference for face-to-face interaction, main- taining a sustainable pace, and permitting the team to pro- duce the deliverable, need to be balanced. The limitations of this review are that the assessments were retrospective (as necessitated by the level of engage- ment required during the pandemic to complete the above projects) and that the number of projects sampled was small. The types of projects sampled met specific crite- ria, and any projects that meet some but not all criteria (eg, COVID-19 impact assessment for a CSR) may require a combination of strategies depending on the context. In addition, in Scenario 2, we were engaged as a resource late in the project planning phase and may have been able to influence the project management approach had we been involved earlier. As we further consider implementation of agile meth- odology in whole or in part, we acknowledge that the agile method of project management assumes that the workers’ time is retained, mostly available, and free of other distrac- tions to be able to pivot. Within regulatory writing depart- ments, resources often cover multiple deliverables over multiple programs, so a shift to properly resource agile proj- ects may lead to a higher overall departmental budget. The ability to potentially get to market sooner, however, may outweigh this burden. This concept also may not be repre- sentative of the way that all regulatory writers want to work and in fact will work best when the team wants to rapidly innovate in a unique way8; commoditization of this way of working could increase the risk for burnout and cause workers to lose faith in the principles of prioritization, trust, teamwork, and problem-solving that are core to this proj- ect management method. Furthermore, this method may require writers with a requisite level of experience to be able to pivot as needed. Considering that experienced writers represent a finite portion of the workforce and given that the demand for this style of working may increase, this could http://www.amwajournal.org AMWAJournal.org 44Agile Strategies in the Rigid Regulatory Environment leave a large gap in the available resource pool that needs to be urgently addressed by leadership in the regulatory writing field. Acknowledgement Synterex would like to thank Fulcrum Therapeutics, Goldfinch Bio, and Moderna, Inc. for their support in writ- ing this article. Editorial credit Jordan Sedlacek, Synterex Inc. Author declaration and disclosures: Jeanette M. Towles and Jason S. Casavant receive funds from several biotech and phar- maceutical companies for regulatory writing services. Author contact: jtowles@synterex.com References 1. Project Management Institute. A Guide to the Project Management Body of Knowledge: PMBOK Guide. 6th ed. Project Management Institute; 2017. 2. Towles J. A brief history of the COVID-19 pandemic and current efforts to combat it. AMWA J. 2021;36(2):64-71. 3. Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research. COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID- 19 related drugs and biological products—guidance for industry and investigators. US Food and Drug Administration website. Published May 2020. Accessed September 3, 2021. https://www. fda.gov/media/137927/download 4. Center for Biologics Evaluation and Research; Center for Drug Evaluation and Research. COVID-19: developing drugs and biological products for treatment or prevention: guidance for industry. US Food and Drug Administration website. Updated February 22, 2021. Accessed September 3, 2021. https://www.fda. gov/media/137926/download 5. Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health; Center for Veterinary Medicine. Statistical considerations for clinical trials during the COVID-19 public health emergency: guidance for industry. US Food and Drug Administration website. Published June 2020. Accessed September 3, 2021. https://www. fda.gov/media/139145/download 6. Coronavirus (COVID-19) update: FDA issues guidance for conducting clinical trials. US Food and Drug Administration website. Published March 18, 2020. Accessed September 3, 2021. https://www.fda.gov/news-events/press-announcements/ coronavirus-covid-19-update-fda-issues-guidance-conducting- clinical-trials 7. US Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health; Oncology Center of Excellence; Office of Good Clinical Practice. Conduct of clinical trials of medical products during the COVID-19 public health emergency guidance for industry, investigators, and institutional review boards. US Food and Drug Administration website. Updated August 30, 2021. Accessed September 3, 2021. https://www.fda.gov/ media/136238/download 8. Rigby DK, Sutherland J, Takeuchi H. Embracing Agile: how to master the process that’s transforming management. Harvard Business Review website. Published May 2016. Accessed September 3, 2021. https://hbr.org/2016/05/embracing-agile 9. Bhardwaj P, Sinha S, Yadav RK. Medical and scientific writing: time to go lean and mean. Perspect Clin Res. 2017;8(3):113-117. 10. Traditional vs Agile project management—which one fits you? Kissflow website. Published September 6, 2021. Accessed July 31, 2021. https://kissflow.com/project/agile/traditional-vs-agile- project-management/ 11. View resource workloads and availability in Project desktop. Microsoft website. Accessed September 2021. https://support. microsoft.com/en-us/office/view-resource-workloads-and- availability-in-project-desktop-3ee16869-68ad-4e63-bcb3- 278ae34f7459 12. How work and duration are calculated with assignment changes. Microsoft website. Published April 7, 2021. Accessed September 2021. https://docs.microsoft.com/en-us/office/troubleshoot/ project/calculate-work-duration-assignment 13. Connect to Project Web pp with Power BI. Microsoft website. Published July 25, 2019. Accessed September 2021. https://docs. microsoft.com/en-us/power-bi/connect-data/service-connect- to-project-online http://www.amwajournal.org https://www.fda.gov/media/137927/download https://www.fda.gov/media/137927/download https://www.fda.gov/media/137926/download https://www.fda.gov/media/137926/download https://www.fda.gov/media/139145/download https://www.fda.gov/media/139145/download https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials https://www.fda.gov/media/136238/download https://www.fda.gov/media/136238/download https://hbr.org/2016/05/embracing-agile https://kissflow.com/project/agile/traditional-vs-agile-project-management/ https://kissflow.com/project/agile/traditional-vs-agile-project-management/ https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459 https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459 https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459 https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459 https://docs.microsoft.com/en-us/office/troubleshoot/project/calculate-work-duration-assignment https://docs.microsoft.com/en-us/office/troubleshoot/project/calculate-work-duration-assignment https://docs.microsoft.com/en-us/power-bi/connect-data/service-connect-to-project-online https://docs.microsoft.com/en-us/power-bi/connect-data/service-connect-to-project-online https://docs.microsoft.com/en-us/power-bi/connect-data/service-connect-to-project-online