Enterprise PPM for life sciences with Clarity, focusing on compliance, innovation, and governance by Rego Consulting.

Behind the Spreadsheets: The Hidden Struggle of Life Sciences Data

Across healthcare, pharma, biotech, and MedTech, organizations are juggling everything from drug development to ESG initiatives and M&A integrations. Yet, without enterprise PPM software, many are still relying on Excel, Smartsheet, or a patchwork of one-off, homegrown tools to manage these complex, high-stakes projects.

However, outdated and unintegrated tools can’t scale, flex, or support the full lifecycle of Project and Portfolio Management (PPM) or Strategic Portfolio Management (SPM). Additionally, these limited tools weren’t built to support all the challenges life sciences projects face, including regulatory stage gates, long project cycles, critical path management, audits, and more.

The result? Organizations are hindered by siloed systems, overengineered processes, and a painful lack of visibility across strategy, resources, compliance, and financials. 

Unacceptable Risk

Manual workarounds and ad-hoc solutions add risk to patient treatment processes and outcomes. The most significant risks include:

  • Delayed Patient Treatment

    • Disconnected systems stall trials and approvals, delaying life-saving therapies.
    • Patients wait longer for the treatments and devices that they desperately need.

  • Safety and Regulatory Compliance Failures

    • Fragmented tools risk noncompliance with FDA, EMA, and other standards. 
    • Missed documentation or traceability can trigger fines, delays, and loss of trust. 

  • Misaligned Priorities and Missed Deadlines

    • Lack of a single source of real-time data turns prioritization into guesswork. 
    • Projects slip, deadlines are missed, and product rollouts are delayed. 

  • Overburdened Teams and Poor Resource Utilization

    • Scattered data causes overbooking, burnout, and idle talent. 
    • Delivery slows, morale sinks, and efficiency is lost. 

  • Inefficient Operations

    • Teams waste time chasing status, managing tools, and rebuilding reports.
    • Collaboration falters, audits cause scrambling, and time is wasted wrangling tools instead of doing actual work.

  • Increased Costs

    • Manual rework and duplicate entry drain time and money.
    • Inefficiency erodes ROI across the entire portfolio.

  • Stunted Scalability and Innovation

    • Legacy tools can’t pivot with shifting regulations or breakthroughs.
    • Growth stalls and opportunities slip away.

None of these risks are worth taking – especially when better, proven solutions already exist.

Rego Brings Expertise and Clarity

Rego is familiar with these risks and has the tools and the expertise to help. As a leader in strategic portfolio management (SPM), Rego helps organizations balance innovation with regulatory oversight and operational execution. They have vast experience in implementing enterprise-grade project portfolio management (PPM) and SPM solutions that support global compliance, projects with long timelines, and cross-functional collaboration.

Rego Consulting was invited to share their expertise at several Why Summits conferences, which are focused on training and inspiring life science professionals with cutting-edge strategies and products.

During Rego’s presentations and discussions, Rego’s expert guides heard similar challenges from project managers and PMO employees. Universally, everyone was passionate and committed to their industry, their organization, and their role. Attendees were particularly concerned about patient outcomes, safety, risks, and compliance. They were eager to understand how modern software solutions could help!

The Rego team was thrilled to introduce Clarity, an enterprise-wide SPM/PPM tool, knowing how much it can improve your day-to-day experience and deliver impactful business outcomes.

Two presenters speak beside a screen showing “Trend 1 – Interconnected and Inclusive Ecosystems” with challenges, opportunities, and steps

Rego experts Wes McCoubrie and Jacob Cancelliere discuss integrated solutions with the Why Summits audience.

Overcoming Life Science’s Unique Challenges with Clarity

Rego understands the unique challenges that you face as a life science professional. Beyond the focus of saving and improving lives, you work in an environment where everything must be traceable, validated, and ready for inspection at all times.

In addition, you encounter hurdles common to all industries such as balancing innovation with execution, managing limited resources, reducing risk, meeting necessary compliance, and maintaining agility while trying to scale.

Banner reads, “You Are Not Alone. A larger community is solving similar challenges with great resources available to you.”

One Platform for All Initiatives

Life sciences organizations balance a staggering range of work! From early discovery and clinical trials to manufacturing scale-up, marketing launches, IT implementations, and corporate sustainability programs, the work can feel endless. Too often, these initiatives live in separate systems, creating silos that slow decisions and hide critical information.

  • Clarity eliminates tool sprawl. Integrating your existing enterprise stack, Clarity unities every project and initiative across every department with a single, governed platform. R&D, Clinical, Regulatory, Quality, Manufacturing, IT, Finance, and Commercial teams can all plan, execute, and report in the same environment.

  • Clarity functions as a true enterprise-wide PPM solution, supporting every type of project, from scientific research to IT upgrades to ESG programs, on one scalable platform.

  • This unified approach breaks down silos and gives leadership one source of truth with real-time data across the entire life sciences value chain, from concept through launch and post-market surveillance.

  • The result? Clarity turns fragmented data into actionable insight and audit-ready evidence, enabling organizations to manage all initiatives with trusted workflows, compliance controls, and reporting standards in one governed workspace.

Here is how Clarity can efficiently support your work:

Functional Area Typical Projects Why Clarity Fits
Drug and Biologic Development IND / CTA submissions

Phase I–IV studies

Post-market surveillance

 Configurable stage-gates, PK/PD scenario planning, eTMF/QMS links, 21 CFR Part 11 audit trails
Manufacturing and Tech-Transfer Process scale-up / tech-transfer to CMOs

Continuous-manufacturing conversion

Serialization and track-and-trace roll-out

 Stage-gate workflows for validation batches; cost and capacity modelling across plants; audit trails for FDA/EU Annex 1 inspections
Quality and Compliance CAPA remediation programs

GxP computer-system validation (CSV) waves

EU MDR / IVDR gap-closure projects

 Formal tollgates, document linking to QMS, 21 CFR Part 11 e-signature capture; real-time dashboards for deviation aging and closure
Regulatory Affairs and Labeling Global labeling harmonization

New indication/line-extension submissions

eCTD 4.0 transition

 Cross-regional timeline management; resource forecasting for authoring; integrated risk registers for “clock starts”
MandA / Divestiture Integration Portfolio normalization

Duplicate-project detection

Synergy-capture workstreams

 Bulk import and tagging, integration-playbook templates, scenario modelling, TBM cost tracking
Clinical Operations Enhancements Decentralized-trial technology deployment

Risk-Based Monitoring (RBM) enablement

Patient-recruitment acceleration  campaigns

 Hybrid agile/waterfall support; scenario analysis for site mix or vendor models; RWE dashboards to track enrolment vs. forecast
Digital Health and SaMD Mobile companion-app builds

Algorithm/software update cycles (post-market)

Real-world data platform implementations

 Agile boards plus Stage-3/4 SaMD design-control tollgates; live backlog prioritization; traceable design-history records
IT and Data-Platform Modernization LIMS or eTMF upgrades

ERP/SAP S/4HANA migrations

Cloud and cybersecurity hardening

 Enterprise-wide demand intake, resource capacity heatmaps, and multi-million-dollar program budget tracking in one place
Commercial Launch and Market Access Global launch readiness plans

HEOR and value dossier creation

Field-force training roll-outs

 Template libraries for launch workstreams; milestone burndown charts; cost-to-launch vs. forecast dashboards
Supply-Chain Resilience Dual-sourcing / reshoring initiatives

Cold-chain optimization

Inventory segmentation projects

 Multi-site portfolio visibility; risk heatmaps linking supply nodes to product revenue; what-if scenarios for lead-time shocks
People and Change Management Competency-based training programs

DE&I initiatives

New ways-of-working (SAFe®, DevOps) transformations

 Portfolio scoring to align training spend with strategic skills gaps; progress KPIs surfaced to HR and executive dashboards
Enterprise Risk and Sustainability Climate-risk mitigation projects

Data-privacy/GDPR remediation

Business-continuity and disaster-recovery tests

 Centralized risk registers with owner assignment; automated status roll-ups into board-level risk and ESG scorecards

Cross-Departmental Coverage
Additionally, Clarity provides the following out-of-the-box features that support cross-department success:

  • Configurable Stage-Gates: Drug-development, device design-control, ITIL, or corporate-finance tollgates – all run on the same engine.

  • Hybrid Delivery Support: Waterfall for validation runs, agile for software iterations, Kanban for continuous improvement – all tracked in one view.

  • Resource and Budget Pools: Finance, QA, Digital, and CMC  each manage capacity constraints – yet roll up to a single enterprise forecast.

  • Unified Risk and KPI Library: Every initiative, whether a cold chain retrofit or a HEOR study, reports into a common risk taxonomy and KPI set – gives leadership a single source of truth.

Benefits of Clarity for Life Sciences Orgs

Regulatory Stage Gate Management and Audit Trails for Life Sciences Projects

In many industries, stage gates are decision points that are used to assess whether a project merits further investment. But in life sciences, stage gates are non-negotiable checkpoints enforced by regulatory bodies. At every step, organizations must prove that what they’ve developed is safe, effective, and ready to advance.

For example, MedTech teams must secure Design History File (DHF) approval before a device can move forward, while pharmaceutical organizations navigate Phase 0–IV tollgates that control every step from first-in-human studies through new drug application (NDA) submission.

And when delays can cost millions, or risk patient lives, streamlining stage gate management is essential.

Clarity supports life science’s unique use of stage gates in five key ways.

  • Enforces Stage-Gate Governance

    Life Sciences organizations manage stage gates that are both high-stakes and highly specific. DHF approvals for MedTech and Phase 0–IV tollgates for clinical trials are just two examples of the critical checkpoints required to demonstrate safety, efficacy, and regulatory readiness.

    • Clarity empowers organizations to configure and enforce workflows, aligning project progress with regulatory expectations and ensuring no critical decision step is skipped. Mandatory approvals, sign-offs, and document attachments reduce the risk of bypassing a regulatory milestone and keep compliance front and center across the portfolio.

  • Centralizes Evidence and Audit Trails
    Regulatory bodies like the FDA and EMA expect a complete, easily accessible record of every decision and its supporting documents.

    • Clarity creates a clear, immutable audit trail for regulators, internal review boards, quality teams, and compliance groups with timestamped approvals, linked documentation, and evidence attachments at every stage. Every action is recorded to meet requirements like 21 CFR Part 11, ensuring teams can demonstrate compliance throughout the project lifecycle and be submission-ready at any point.

  • Provides Real-Time Status Visibility
    In life sciences, timelines often span years, and regulatory scrutiny is relentless, meaning teams can’t afford blind spots or outdated information. Yet many organizations rely on static reports and fragmented tools that only offer backward-looking snapshots, slowing decisions and creating compliance risk.

    • Clarity centralizes project data into one real-time platform, uniting reporting across budgets, schedules, dependencies, risks, and deliverables, all the elements regulators expect to see during audits or inspections. Executives, clinical operations, and regulatory affairs teams can instantly see which studies are progressing and which are stalled at a tollgate. Customized dashboards highlight overdue decisions, resource bottlenecks, and budget impacts, so leadership can act before delays escalate. Whether prepping for an internal review or responding to an external regulator, Clarity gives teams the transparency they need to stay aligned, move quickly, and maintain trust.

  • Enables Scenario Planning
    Life Sciences portfolios are full of uncertainty. For example, if a Phase II trial underperforms, teams need to decide quickly whether to pause, accelerate, or cancel before committing to Phase III.

    • Clarity integrates scenario planning into the stage-gate process, allowing portfolio managers to model the budget and timeline impact of these choices. Predictive analytics provide risk scoring and resource forecasting, so teams can weigh trade-offs before taking action.
  • Improves Cross-Functional Alignment
    Tollgate reviews span Clinical, Regulatory, Safety, and CMC teams. And too often, the process and data sprawls across emails, spreadsheets, and local trackers.

    • Clarity acts as a single collaboration hub, replacing disconnected tools with one system where documentation, sign-offs, and approvals live together. Every stakeholder sees the same version of the truth, improving accountability and accelerating decisions.

Governance and Regulatory Compliance in Clinical and Commercial Operations

In life sciences, governance isn’t just guidance, it’s proof of control. Every decision must be traceable, justified, and aligned with a complex network of regulatory expectations. Organizations must balance internal governance with external accountability, spanning everything from financial oversight to safety programs like Pharmacovigilance and councils that monitor compliance.

  • Clarity embeds governance directly into project lifecycles. Portfolio prioritization, risk scoring, change management, and financial approvals are tied into configurable workflows that align with FDA, EMA, ISO, and other standards.

  • The result? Decisions are transparent, documentation is preserved, and compliance is simply part of how the work gets done.

Integrated Document Management for FDA-Ready Submissions and SOP Traceability

In life sciences, documentation isn’t a formality, it’s required proof. From protocols and SOPs to regulatory submissions, teams must maintain airtight control over documents across long project timelines and frequent handoffs.

  • Clarity directly links critical documents to related projects, gates, and workflows, making them traceable, current, and easily accessible.

  • When integrated with document control or quality systems, Clarity ensures that key materials, such as GxP (“Good [industry] Practice”), DHF records, and clinical trial protocols, remain compliant and audit-ready. No more scrambling for evidence, putting your project and company at-risk.

Real-Time Portfolio Visibility and Standardized Reporting for Regulatory Readiness

When timelines stretch over many years and regulatory scrutiny is constant, teams can’t afford blind spots. Yet many life sciences organizations rely on static reports and fragmented tools that offer only backward-looking snapshots. That means they can’t respond quickly to changes or prove compliance.

  • Clarity centralizes project data and provides united reporting in one real-time platform. Teams gain anytime access to live data with customized views of budgets, schedules, dependencies, risks, and deliverables – all the elements crucial for audits, inspections, and confident decision-making.

  • Whether you’re prepping for an internal review or responding to an external regulator, Clarity provides data transparency to act quickly, stay aligned, and maintain trust.

Configurable PPM Workflows for Global and Country-Specific Life Sciences Compliance

Each life science company operates uniquely, especially if spanning multiple countries and product lines. Whether managing GxP audits, clinical trial readiness, or post-market surveillance, tools must flex to meet the demands of multiple regulatory bodies without needing to rebuild systems from scratch.

  • Clarity adapts to the standards where you’re operating, including global, regional, and local. Customizable workflows enable country-specific compliance requirements, and also maintain consistency at the portfolio level.

  • Clarity also supports processes that help life sciences organizations meet key regulatory standards, including FDA requirements like 21 CFR Part 11 to ensure secure, validated electronic records and signatures.

  • You can scale operations without compromising oversight or agility, even when managing diverse products across multiple locations.

Managing Long-Term Life Sciences Projects with Full Oversight and Flexibility

Many life sciences projects run for 15 years or more, changing dramatically along the way. Outcomes aren’t always predictable, but oversight is always required.

  • Clarity helps teams manage the long arc of complex projects by tracking evolving dependencies, surfacing risks early, and maintaining continuity – even through staff turnover or organizational changes.

  • With in-tool history, audit trails, and scenario planning, Clarity equips teams pivot intelligently, without losing sight of regulatory or strategic goals. Teams can model what-if scenarios to evaluate the impact of changing priorities, budgets, or timelines to make the best decision.

Flexible Project Delivery for Waterfall, Agile, and Regulated Life Sciences Teams

Life sciences teams don’t all work the same way: pharma often runs waterfall, MedTech leans agile, and biotech blends both. Too often, tools force a single method or fail to support any structured approach.

  • Clarity supports hybrid delivery methodologies, allowing teams to manage stage-gated compliance alongside agile execution.

  • Teams remain responsive and innovative without losing visibility or control. Whether managing a 10-year pharma pipeline or a fast-moving MedTech release, Clarity keeps everything aligned and on track.

Three colleagues celebrate success while looking at a laptop together in a bright office.

In summary, Clarity is a comprehensive platform that provides a centralized, transparent, and fully auditable system of record for all project, program, and portfolio activities. It empowers organizations to get up and running quickly with unified data, real-time insights, and built-in best practices. It simplifies strategic alignment, resource management, project scheduling and execution, financials, compliance, and reporting into one cohesive solution.

Testimonials Straight from the Why Summit Floor

Why Summit attendees had overwhelmingly positive feedback, and it is easy to see why. They were delighted how much can be done within Clarity’s comprehensive platform. It was a surprise to many that a single platform could replace their tool sprawl, unify data, support real-time reporting, and simplify everything from compliance to strategic alignment.

Collectively, they were encouraged to learn:

  • They are not on their own when facing the unique Life Sciences challenges!
  • They don’t have to keep reinventing the wheel or mitigating risks with home-grown solutions.
  • There are exciting tools to explore, and they are curious to know more.

As one attendee shared, “The level of dialogue, the energy in the room and the willingness to share best practices made this an outstanding learning and networking experience. From deep discussions on innovation-driven portfolio design, optimal governance / resource allocation setup, projects selection and prioritization and performance measurement monitoring, to practical case studies and powerful panel discussions – this event truly delivered.”

Get Started Today

You don’t need to reinvent the wheel or build from scratch. But it’s time to rethink your toolset.

Graphic of climbers with text, “Rego offers tailored Clarity solutions to meet Life Sciences needs and guide future goals.”

Two men stand smiling behind a monitor displaying Clarity project portfolio management software. Clarity is affordable, flexible, and capable of growing with your organization. It simplifies every aspect of project and portfolio management, from scheduling and resource planning to financials, compliance, reporting, and strategic alignment. With built-in best practices, rapid implementation, and flexible scalability, Clarity supports both operational and executive needs. It’s easily customized to fit your organization’s unique requirements, methodologies, and stage of growth, providing a powerful foundation that grows with you.

Rego can help your organization get up and running fast and deliver long-term ROI. Our expert guides bring decades of cross-industry Clarity experience, fresh perspectives, and humility. We offer cross-industry insight and practical guidance, adapted to each client’s culture, maturity, and goals.

If your team is ready to simplify operations, streamline compliance, and unify your portfolio tools, Rego is ready to help. We support a large SPM/PPM community who have overcome the challenges you are facing now, and we’re ready to support you.

Let’s work together to make sure your tools are supporting your strategy, not holding it back.

Additional Resources

Learn more about Clarity, project management, and more for your life sciences organization:

Learn how Rego can help you at any stage of your journey:

Silhouette of climbers helping each other ascend a peak with text “Let Rego be your Guide.”

Let Rego Be your Guide

As industry leaders, we’ve refined best practices in PPM for more than 700 organizations, across every industry. We would be delighted to show you how we can meet your Clarity consulting needs. Contact us for a free health assessment or demo today.

For a full list of Clarity PPM services, visit regoconsulting.com.

About the Author: Rego Consulting

As the leading Strategic Portfolio Management (SPM), Project Portfolio Management (PPM), Technology Business Management (TBM), Agile and expert services provider, Rego Consulting has helped hundreds of organizations achieve a higher return on their software investment, including 60% of Fortune 100 and 70% of Fortune 20 companies.

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