Annual planning is an opportunity to fix this long-standing clinical operations issue
At the beginning of many pharma companies’ financial year, an annual planning process occurs. This presents an opportunity for stakeholders to align on short-, mid-, and long-term goals.
Clinical stage pharma companies focus on clinical-trial related goals. These include completing ongoing clinical trials and initiating new ones, in the context of the company’s commercial plans as well as market pressures.
Clinical operations executive leaders within these companies can use this planning process to make investments that address common barriers to achieving their department’s goals:
- Lack of sufficient resources
- Incomplete data aggregation
- Inadequate technology support
These problems are often related and represent different aspects of the same issue – inefficient processes and low productivity:
- Clinical Program Managers (CPMs) may say that they experience the greatest challenge at the start of each new study. Site activation, patient screening/recruitment, and vendor selection don’t seem to get easier, despite prior experience.
- For Clinical Trial Managers (CTMs), having timely and meaningful access to aggregate and singular data across their study’s lifespan is the most excruciating challenge. Maintaining scores of study trackers and navigating multiple data systems to do this, leads to manual work, uninformed decisions, burnout and subsequent employee turnover.
- Company Executives will say that having access to accurate data so they can avoid uncertainty and make informed portfolio/strategic decisions, is one of their critical responsibilities. This element could severely impact commercial targets, budget allocation, and funding.
Clinical trial issues can affect a company’s viability and image in the marketplace
Trial timelines and outcomes may determine whether the company itself becomes successful. Small biotech companies, for example, rely on these to signal if they can remain financially viable. Large companies, on the other hand, are pressured by investors to become ever more efficient, to increase bottom-line growth. They’re also pressured by the market to innovate and remain competitive in a fast-changing world. So, producing high quality clinical trial data – efficiently – is critical for all companies.
Thus, all clinical operations stakeholders would agree that maintaining updated clinical trial data, while having the ability to analyze them in real-time, throughout the duration of the studies, is the Holy Grail of clinical operations, and a key to meeting study milestones.
However, current standards of systems and workflows do little to accomplish these feats. Instead, key trial milestones are repeatedly missed, leading to delayed timelines and increased operational expenses.
Beware of investments that make things worse!
Companies sometimes hire external consultants to identify strategies to manage this:
- First, an in-depth review is done
- Next, perhaps a recommendation made to source and implement more complicated technology
- Or, a recommendation made to change a team’s structure: reshuffling staff and adjusting their scope of work as needed – including hiring new people to manage extra workflows
Ultimately, these tactics add further complications and do little to improve efficiency. In fact, they often worsen the situation.
The right investment
Bridging these productivity gaps is Seascape Clinical‘s mission. We believe that clinical operations oversight (and thus trial conduct) need not be complicated. However, it requires that right tools to guarantee on-time delivery of high quality data.
An efficient Clinical Trial Oversight Solution should enable recurring workflow automation and reduce manual entry to lower total workload. It should also ensure data quality and provide actionable insights that maintain timelines. Here’s how:
- Proactively reduce errors introduced by manual entry
- Flag trends and risks in real-time regarding site activation, enrollment, visit assessments, or vendors
- Allow timely collaboration between team members and external stakeholders (sites, vendors)
- Be bundled with services that fill workflow gaps that even the best technology can’t address. This allows a smooth user experience that avoids the user needing to create work-arounds or SOPs.
Doing more with less without compromising quality, while meeting business targets is exactly what our solution, ClinOps Pro, does.
From first subject screened to final study readout, ClinOps Pro provides complete data collection from all trial data sources and updates study trackers on a predetermined schedule. ClinOps Pro also produces unified dashboards for visualizing KPIs, relevant to individual subjects, sites, or specific trials.
ClinOps Pro combines a cloud-based platform and support services designed to improve clinical operations productivity at all levels for pharma companies.
