Pharmaceutical project management software: How to achieve good governance

In 2016, the FDA approved less than 50% of drugs submitted for approval the previous year. This stark number exposes just how difficult pharmaceutical projects can be to manage.

This white paper examines the reasons behind low approval rates and offers insights into cost models involved in taking a drug from discovery to patient. Pharmaceutical project management software is one tool that helps manage complex timelines and keeps drug development on track.

For pharmaceutical teams running clinical trials, R&D pipelines, and regulatory submissions, the right project management software can mean the difference between a successful launch and a costly delay.

Key takeaways for pharmaceutical project management

1. Drug development takes ten years on average. Clinical trials alone consume six to seven years. Pharma project management requires a platform that supports long-term planning and multi-project management across the entire development lifecycle.

2. Regulatory compliance demands document control. Pharmaceutical teams must maintain strict documentation standards. Quality management software with built-in audit trails and workflows makes compliance straightforward rather than burdensome.

3. Resource management determines project success. With specialized talent in short supply, effective resource allocation across pharmaceutical projects is not optional. Management software that tracks capacity and assignments helps teams avoid bottlenecks.

4. An EPMO provides strategic oversight. An Enterprise Project Management Office standardizes processes and improves visibility across the portfolio. This structure helps organizations respond quickly to changes and work more efficiently.

5. PPM software accelerates decision-making. Real-time visibility into your drug development pipeline lets leadership create informed decisions faster. The right features enable pharmaceutical teams to spot risks before they become problems.

Pharma faces rising costs and regulatory pressure on projects

The pharmaceutical industry faces escalating costs, stringent regulations, and extended timelines. Competition continues to intensify while market demands evolve rapidly.

Pharmaceutical companies that fail to optimize their processes fall behind. A collection of disconnected tools and manual tracking methods simply cannot keep pace with what modern drug development requires.

Pharmaceutical project management software handles complex tasks

The pharmaceutical sector faces project management challenges unlike any other industry. The development lifecycle spans discovery, R&D, clinical trials, and marketing. Each phase carries distinct risks and requires precise coordination.

Project Portfolio Management (PPM) software addresses these challenges directly. It serves as a tool that helps manage complex timelines while providing the visibility pharmaceutical teams need to stay aligned.

Small teams and large organizations alike benefit from a unified platform. The software centralizes tasks, automates workflows, and provides one source of truth for all project data.

An EPMO builds efficiency across pharmaceutical projects

An Enterprise Project Management Office (EPMO) transforms how pharmaceutical companies manage their portfolios. It establishes clear processes, standardizes operations, and improves visibility across every project.

With the right governance structure, organizations respond swiftly to changes. Teams can work on what matters most while leadership maintains oversight of the entire pipeline.

PPM software gives pharmaceutical teams real-time visibility and features they need

PPM software provides pharmaceutical project managers and senior leadership with real-time visibility, control, and insights into their drug development pipeline. Project management software streamlines project tracking, communication, and risk management.

These features enhance decision-making and help companies accelerate time-to-market for life-saving drugs. When teams can see status, resource allocation, and risks in one place, they work faster and smarter.

Resource management software aligns teams to priority work

Pharmaceutical organizations juggle multiple projects with overlapping timelines and shared resources. Resource management capabilities within PPM software let managers see who is available, who is overallocated, and where gaps exist.

This visibility helps teams assign the right people to the right tasks. Better resource planning reduces delays and keeps pharmaceutical projects moving forward.

Document control and quality management software support compliance

Regulatory bodies require extensive documentation throughout drug development. Document control features within pharmaceutical project management software maintain version history, track approvals, and provide audit-ready records.

Multi-project management keeps the portfolio on track

Most pharmaceutical organizations run dozens of active projects at any given time. Multi-project management capabilities provide portfolio-level visibility so leadership can make informed trade-offs.

When one project hits a snag, teams can quickly assess the impact on other initiatives. This connected view helps organizations protect their most strategic investments.

The reality of pharmaceutical project timelines

From the white paper:

Even though technology has changed the pharmaceutical sector forever, the scientific processes and methodologies are still understandably thoughtful, deliberate, and oftentimes slow. Speeding up research projects has dangerous consequences. Making scientists accountable for success-driven projects is also fraught with danger.

On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average.

The harsh reality is that through increased consumer demand, shorter research and development lifecycles, and cut-throat competition, the pharmaceutical industry is moving faster than ever. Massive organizations need to change and change fast if they are to survive.

This pressure makes the right pharmaceutical project management software not a luxury but a requirement.

Take control of your pharmaceutical projects with Cora

Pharmaceutical project management does not have to mean endless spreadsheets, missed deadlines, and compliance headaches. The right software gives your teams the platform they need to manage tasks, track resources, and maintain the document control regulators require.

Cora's PPM software is built for organizations running complex, high-stakes projects. Our pharmaceutical teams customers use it to coordinate clinical trials, manage R&D portfolios, and bring life-saving drugs to market faster.

Ready to see how Cora can work for your organization? Request a demo and discover how pharmaceutical project management software can transform your operations.