Pharma is booming, and the race to bring new drugs into the market has never been closer. This has forced drug manufacturers to focus their attention on one of the most simple and cost-effective ways to improve their processes – effective project management.
Over recent years, the pharmaceutical & Life Sciences industry has undergone major shifts both within the sector and in the external environment. These changes come in the form of stringent regulatory requirements, fierce competition, rising costs for Research & Development, a demand for better healthcare for an ageing population, and company mergers within the industry. All of which have had a significant impact on how companies bring new drugs to the market – heightening the need for agility, restructuring, cost reduction, and culture change projects.
Pharmaceutical & Life Sciences companies have a lot to contend with currently – with being in one of the most heavily regulated industries in the world, they must scramble to find new ways to develop their products faster, within budget, and meet rigorous quality standards. This is why organisational leaders have begun to appreciate the positive impact that effective project management has on their bottom line.
In this blog, we explore the role project management plays in helping those in the pharmaceutical & life sciences sector to address their regulative, quality, and safety needs. We drill into the key complexities in project management and explore the many ways project management tools can assist teams to effectively understand their mission critical projects – and manage the associated tasks and risks.
Why Project Management is Essential
In the pharmaceutical & Life Sciences sector, project management plays a major role in supporting teams throughout the entire lifecycle of product development. From research, development, and testing through to manufacturing & production, everything must be planned out meticulously with clear ownership. These complex projects must also take into account regulatory requirements and quality control guidelines, as well as carefully managing the associated risks to ensure everything stays on track.
Two enormous challenges the pharmaceutical industry grapples with today are quality-related checks and extensive product development processes & schedules – both of which can be directly addressed with effective project management.
When done right, project management has a tremendous value and the potential to significantly increase the success of the product or service being delivered. Well managed projects provide structure to complete key project stages like:
- Clinical trials.
- Filing new drug applications.
- Obtaining approvals.
- Working with marketing, advertising, and communications divisions,
- Navigating the challenges & risks the early stages of a drug launch and commercialisation can bring.
Complexity of pharma projects
It’s clear that being in such a closely regulated industry, pharma companies don’t have much choice but to manage their strategic projects in an integrated manner or face the consequences. Key considerations when managing complex pharma projects include:
- How will teams objectively assess multiple ideas and decide where to allocate budget and resources.
- How will stakeholders get a real time view of project status and track progress.
- How will you structure business processes that fit your unique project management requirements.
- How will you get diverse functional teams to collaborate and communicate.
- How will you ensure project risk is proactively managed and that sufficient controls are in place.
- How will you create and maintain documentation, supporting details and cross-references – in a structured manner that satisfies authorities.
- How will you closely track timelines and actual costs for projects to understand status.
- How will you consolidate data to get a single source of truth.
- How will you access the right data & analytics to drive strategic project decisions.
How Project Planning Tools Can Help
In an industry where executives are constantly looking for ways to improve operational efficiency and support the bottom line in a challenging marketplace – traditional manual processes such as spreadsheets, emails, shared drives, and documents just don’t cut it. Especially because it creates inefficiencies when collaborating on projects and tracking progress amid a multitude of dependencies and risks. Consequently, they are turning to specialist project management tools that support the delivery of critical – and complex – projects by establishing a structured framework that fosters effective collaboration and facilitates transparent information sharing amongst teams.
Specialist software allows pharma companies to understand projects – and the associated tasks & risks – using a structured framework that provides the foundation for holistic management – and the benefits are compelling:
- Ability to break down larger projects into smaller programmes, tasks, and actions to easily track project status.
- Assign ownership of each element of the project creating accountability.
- Adds a layer of governance & structure, ensuring important milestones are not missed.
- Ability to create a project risk log and monitor risk & set controls to ensure projects remain on track.
- Captures information in a consistent format improving data quality and subsequent reporting.
- Maps key milestones & timelines and prompts staff to tick off the status of completed tasks.
- Facilitates structured sign off and approval workflows for senior stakeholders.
- Provides financial oversight with the ability to map budget plans & forecasts, track estimates, get budget approvals, log expenditure, and capture unforeseen costs.
- Log purchase orders and invoices to reconcile expenditure throughout the project lifecycle, with everything date and time-stamped and documented.
- Track the resources and time spent on specific areas of a project, enabling leaders to plan resources accordingly.
- Link project management to legacy systems via application programming interfaces (APIs), allowing operational data to feed into the project management process.
- Link projects to your strategic objectives to prioritise the most critical projects.
Managing Multiple Stakeholders
The successful delivery of projects is underpinned by a variety of stakeholders – both internal and external.
In the world of pharma franchise distribution and manufacturing, contractors fulfil an important role. For example, working with third party pharma manufacturers to redistribute products or manufacture new ones, adds a layer of complexity to the project management process.
The ability to set up workflows – with dependencies – for specific stages of a project is particularly useful when multiple stakeholders are involved. Projects are sometimes hindered by task bottlenecks, preventing stakeholders from completing their tasks on time because previous steps have been delayed. Specialist project management tools can be used to implement workflows that send automated notifications when specific tasks are completed, or the required approval has been authorised. This allows each stakeholder to commence their task without delay – driving efficiency.
Enhanced Data Sharing & Communication
Project management software facilitates efficient data sharing across teams and stakeholders. This single-pane-of-glass view allows stakeholders to track the progress of each stage of the project via an intuitive dashboard – and understand the role they play in the project management process. Laborious progress meetings subsequently become unnecessary due to the oversight provided by the software.
Empowered by valuable insights at the touch of a button, leaders can manage projects more efficiently, eliminating the need to chase staff for status updates. This provides the structure and understanding required to achieve a holistic approach to project management that’s driven from the top-down and implemented from the bottom-up throughout the project lifecycle.
Project management software supports collaboration across teams and departments, ensuring consistent processes are implemented throughout the organisation. Real-time dashboards – which can be viewed by all stakeholders at any time – and built-in reporting functionality allows progress reports to be produced instantaneously for individual tasks. These can be used to guide the allocation of resources & budgets across multiple projects and balance workload & expenditure.
Improved Governance, Risk and Compliance
Mature pharmaceutical organisations use project management software that is augmented by governance risk and compliance (GRC) capabilities, and strategy management and incident management tools. This added functionality offers several benefits:
- Software solutions that incorporate risk management ensure project-related risks are added to the risk register and tracked. Controls can be established to mitigate risks using key risk indicators (KRIs) and tolerances.
- Software solutions that incorporate GRC capabilities consider the compliance requirements of all projects. These requirements can be linked to the obligations register, allowing necessary adjustments to be made when a relevant regulation changes or is created.
- Pharma companies that harness strategy management tools can link projects to their overall strategy and leverage progress functionality to understand their ability to achieve organisational goals.
- Best-practice incident management tools can be used in conjunction with project management software. This enables all project-related incidents to be logged and managed through to resolution. Automated alerts can be used to ensure relevant stakeholders are notified immediately. Root cause analysis can also be conducted to understand how an incident happened and proactive measures can be implemented to mitigate future occurrences.
Embracing Project Management Software
As pharma companies face growing challenges in market desires, along with regulatory, quality, and safety requirements, changes and updates in their business processes become exhausting tasks to accomplish when using manual processes.
Project management tools such as Camms.Project enhance the implementation of key projects and initiatives by adding structure & automation. This enables pharma companies to optimise the management of clinical trials, enhance record keeping and pharmacovigilance measures, and to accelerate drug discovery methods – ultimately helping companies to improve patient outcomes.
To find out how the Camms project management tool can add structure and ownership to your project & portfolio management process, request a demo today.
Catch up on our other blogs in the Pharmaceutical & Life Sciences Series:
Managing Risk in the Pharmaceutical & Life Sciences Sector
Managing Compliance in the Pharmaceutical & Life Sciences Sector
Effective Strategic Planning in the Pharmaceutical & Life Sciences Sector