Clinical Project Managers Stuck Betwixt and Between

Why today’s project leads need to evolve their role as part of strategic contract research organizations

To keep pace with new expectations, sponsors demand that their CRO project managers (PMs) have next-level competencies. In the past, PMs followed defined processes to complete clinical activities on time and within the scope of the sponsor’s objectives. They worked according to simple management practices, adhering to the triple constraints of time, cost, and quality.

Now, PMs must add new responsibilities for risk management, governance, innovation, and return on investment (ROI). They must have the management skills to communicate and engage with larger internal teams, external vendors, and customers. In addition, PMs must be proficient in analyzing larger subsets of data to pinpoint the outliers and report results to sponsors.

Rather than putting out fires, new expectations include proactively identifying key risk indicators that can affect trial results. Taking the role of “CEO” of the project, these leaders must look at the entire project cycle to ensure objectives are aligned with sponsors’ goals, while finding new opportunities to decrease cost and speed time to market.

EightSpokes named among the most innovative startups!

PM360’s Innovations Issue was established six years ago to serve as a comprehensive guide of the year’s most innovative Companies, Divisions, Startups, Products, Services, and Strategies. PM360 received more than 100 total submissions this year and picked the best in each category.

EightSpokes is among our selections for the most innovative startups of 2017!

In late 2012, Andy Mehrotra, a former commercial excellence leader at Abbott, founded EightSpokes. The company’s vision: To redefine project management and create a new type of project management software designed to enable the highly complex and high-stakes projects in life sciences. The company has established a new category of software called Enterprise Project Collaboration (EPC) and formally launched its cloud-based Enlighten solution market-wide this year.

Enlighten allows companies to more efficiently manage multifaceted, multi-year projects such as new product launches, by connecting people, information, and workflows globally in the cloud. Just as important, it ensures companies retain tacit knowledge so teams can learn from projects and people that came before them, and inspires project leaders to focus on driving business outcomes—not just timelines.

Enlighten brings together all internal and external stakeholders onto a single platform for streamlined communication, coordination, and collaboration. Early adopters, such as Edge Therapeutics, have reported time savings of at least four hours per person a week.

The Increasingly Important Role Of Project Manager In Life Sciences

Life sciences projects are unconventional in that they are heavily regulated, longer, more complex, and dependent on clinical outcomes. 

Drug development uses a phase-gate and waterfall approach, much like other industries, though the unpredictability of a human body’s response to novel therapeutics makes these projects very complicated.

In performing their jobs, PMs in the life sciences are taking on more cross-functional responsibilities. And while asked to wear many hats, they must still ensure the final product or program is delivered on time, within budget, and in compliance. To make their work even more challenging, life sciences PMs are often not equipped with advanced technology needed to assist them in their tasks and are often stuck using rudimentary spreadsheets or limited applications not designed for specific industry needs.

Simply completing tasks on-time, on-scope, and on-budget rarely produces stellar outcomes for any project. By ensuring a high standard of work quality for each completed deliverable, project managers can achieve exceptional outcomes. Consider the impact of delivering and receiving feedback from team members at every step of a drug development program or commercialization project. When project teams know how their work affects the total project, that others care about the quality of work, and that deliverables are more than checks on boxes, engagement gradually rises… as does performance.

EightSpokes introduced Peer-to-Peer (P2P) Feedback with its latest release of Enlighten

Enlighten, the world’s first cloud-based Enterprise Project Collaboration (EPC) solution enables real-time feedback from colleagues collaborating on a project – from drug development to commercialization

With P2P Feedback, users can ensure that every assignment achieves its intended outcome and that team members receive timely and relevant feedback to course-correct as needed, while it still matters. It also naturally propels organizations to continuously improve performance, ultimately ratcheting employee engagement enterprise-wide. 

P2P Feedback allows colleagues to privately offer candid feedback to one another without reprisal from superiors for continuous improvement over the course of a project. In the Enlighten dashboard, all task assigners are alerted when a task is completed. Then, they are asked to rate the quality of the work completed using a simple scale of one to five stars. The tool then enables assigners to fine-tune their assessment using various attributes of work quality, such as accuracy, completeness, and resourcefulness. Last, assigners can provide freehand feedback to add clarity or provide suggestions. Enlighten EPC connects and aligns everyone who touches a project – from regulatory, medical affairs, and market access stakeholders…to sales and marketing teams.

Operational Excellence: The Low-Hanging Fruit to Commercial Success

Even as new drug development focuses more on precision medicines, disconnected software applications force life science companies to continue struggling with imprecise workflows and outdated operating practices…reminiscent of the dark ages

Even with so much time, effort, and money on the line, many companies still rely on outdated technologies to support internal processes. It’s the biggest risk to the success of even the best-planned product launches. These legacy applications create information silos, causing friction in data exchange and gaps in knowledge that ultimately restrict collaboration. And as the number of stakeholders and outsourced partners increase throughout the drug development life cycle, companies cannot afford information bottlenecks that slow activity, or worse, jeopardize outcomes.

Without the right collaborative technologies, sharing information becomes a weekly chore of creating static status slides that quickly become outdated. Lack of visibility and insufficient clarity of accountability leads to frequent rework, which adds cycles of reiteration for deliverables. Without efficient mechanisms to capture and analyze data, many companies reinvent the wheel for each new drug candidate, unable to capitalize on the knowledge gained through past experiences.

Evolution of the CRO Project Manager

As clinical project managers become more strategic, more advanced technology must support their evolving roles

Traditionally, project managers followed a defined scope of work to complete clinical activities on time and within budget. They worked according to simple management practices, adhering to the service triangle of time, cost, and quality. Now, CROs have greater expectations for PMs to proactively manage and control processes and offer innovative solutions to risk - all with an eye on improving ROI. Many are tasked with managing even larger groups of stakeholders composed of internal and external team members as well as customers. 
 
The generation of large subsets of data from various sources requires advanced analytic skills to pinpoint outliers and report results to sponsors. Rather than be reactive to problems, PMs must work proactively to mitigate risk before it causes delays, added costs or other problems.   As ‘CEO’ of the project, they must govern the entire project cycle to ensure milestones are met in alignment with sponsor objectives while finding ways to decrease cost and speed time to market.

Driving Down Launch Costs and Timing with EPC

Edge Therapeutics, a young biotech,  finds a better way to get ready for launch

In 2015, 29 new drugs were launched in the U.S. and all of them experienced some delay, ranging from 5 to 87 days with the average at 45 days delay. The price of such massive delays in today’s competitive marketplace can be, on average, $1 million per day, which is unacceptable. now, with more pressure to bring down drug prices, life sciences companies need to plug the holes of leaky processes. Many are turning to modern cloud-based technologies but few are considering the role that improved project management can play in making a real difference in time to market.

At a small company, things are constantly in motion, and you don’t have a lot of staff or layers of expertise to manage them all comfortably. In launch planning, you have to work out different scenarios for various timelines and departments—clinical, regulatory, marketing and more.

When I started at Edge, our corporate objectives were not closely aligned with either our processes or technology, so there was no way to visualize the integration across functions, the interdependencies between teams and individuals. This also made it more challenging to focus organizational resources around common key goals. Nevertheless, we were getting much closer to starting our Phase 3 and ultimately launching our first product. Being well aware of this common challenge in growth oriented biopharmaceutical companies, I was determined to avoid misalignment from affecting us and wanted to establish processes and organized workflows that would enable company wide collaboration and execution against our shared objectives.

I had personally worked with a number of standard project management systems and supporting tools and so considered all options—including Microsoft Project as well as other enterprise project and resource management systems.

I was prepared to invest in Microsoft Project Online but was concerned it was solving our issues with a sledge hammer. We needed a solution that was agile and flexible and had the reporting and capabilities we would use in the real world. Edge couldn’t afford to invest in functionality that we didn’t need, and then be required to additionally invest in add-ons like reporting tools to just get the basics done. Plus, we couldn’t afford to invest our people in maintaining the upkeep of a system like MS Project Online. I knew, once we started, the consulting and maintenance fees would only go up.

Clinical-Stage Biotech Selects Collaborative Enterprise Technology

Justin Zamirowski, Edge Therapeutics’ Senior Director of Operational Excellence, and Andy Mehrotra, CEO of Boston-based cloud software developer EightSpokes, discuss how a new, collaborative approach to managing projects across the enterprise is improving time to market.

 

Challenged with managing workflows and limited organizational resources, our company lacked sufficient technology to support operational processes and provide transparency into team interactions.  As a result, business leaders could not visualize their programs’ statuses in a timely fashion and proactively make decisions on important activities. 

With an increased focus on pricing and mounting regulatory scrutiny, today’s life sciences companies are under intense pressure to drive down costs while speeding time to market. Joining the company to lead the critical late-stage development, pre-launch preparation and commercialization planning for its drug innovations, I recognized the need to establish an agile workflow management approach for precise commercial execution, not only for a successful global product launch but for sustained long-term growth of the organization. 

While not pinned down by legacy systems and incompatible applications like many pharmaceutical organizations, Edge still needed to establish a system of record that managed its processes across the organization. I wanted a work management solution that offered visibility into work activities so team members could prioritize and make better decisions that supported corporate objectives. I also wanted a cost-effective and flexible solution that supported alignment, teamwork, and improved decision-making. An enterprise project collaboration platform provides a crucial bridge to connect stakeholders seamlessly and transparency so we can spot issues before they cause delays.

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Yanina Wolfe, a client success manager at EightSpokes, explained that improving KPI tracking is about much more than just providing progress updates. "It's about having the necessary information to make the right decision and to address issues before they spiral out of control," she said. "There are new types of enterprise project collaboration applications emerging that bring together all stakeholders involved in a project across the enterprise, globally, including external partners. These solutions are cloud-based, so they are easily accessible to various users wherever they work." Wolfe believes the key to tracking KPIs and running an effective project efficiently is visibility: "When managers can get an accurate picture of the entire project, they can more easily track key data, and all of the players can better collaborate."

EightSpokes’ New Offering Can Increase Your Organization’s Productivity by Up to 40%

Enlighten is collaboration management designed to facilitate seamless information exchange between cross-functional teams to accelerate drug development and commercialization in life science companies. 

A project management solution, such as Microsoft Project or Oracle Primavera, is typically used by the project manager to create the project plan and then assign tasks to different members of the project team. The project manager keeps track of the team members’ progress, and puts that information into the project management software to create slides and information for business stakeholders. Then the business leaders react to that information and provide feedback to the project manager who uses that to determine what and how things should be done differently. This is the way things get done today—with the project manager sitting in the middle.

What we have created is a project collaboration solution, which means all the team members, the project manager, and the business leaders are simultaneously on the solution. Every team member knows what their prioritized tasks are for the day in one project or across a number of projects. The project manager doesn’t send that information—the system sends it automatically—enabling project managers to divert their efforts to more value-add tasks.

Enterprise Project Collaboration - The starring role it can play in driving down costs of drug development and commercialization

A shift from traditional project management practices, EPC is designed to accelerate drugs to market

Life sciences companies still operate in the dark ages in many ways when it comes to technology. Even as the industry pivots away from blockbusters to develop advanced, specialized medicines (Express Scripts says specialty meds will account for half of all drug spend in 2018), the technology supporting this ground-breaking work is anything but cutting edge. Many organizations are frustrated with this paradox, yet still rely heavily on legacy software to manage the intricacies of drug development and commercialization. Hoping to streamline processes, companies of every size continue to tack on off -the-shelf software to old ERP systems. Instead of simplifying tasks, these multiple and unrelated applications increase the burden and costs while adding confusion that reduces teams’ speed of execution. As a result, incredible inefficiency pervades, delaying the introduction of new therapies to market.

Project management—with a social-media gloss—is offered for pharma new-product launches

The Enlighten platform brings up-to-the-minute workflow practices to pharma projects

Project management software used to be static flowcharts of activities and team responsibilities, updated periodically, and for many business tasks, it remains that way.

But the more modern approach, seen in some customer relationship management (CRM) systems or so-called “human capital management” systems is to put all the members of a project team (including outside collaborators) on a unified platform, with interactions shared among participants, and project status continually updated in near real time.

Those are some of the guiding principles of a new software offering, Enlighten, from EightSpokes, Inc. (Cambridge, MA).

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