When people think of large pharma companies, they think of endless resources that can move mountains. But with this large size comes high complexity, and therefore, unique clin ops pain points.
Below, in no particular order, we’ve identified the top 5 large pharma pain points in clin ops (as well as potential solutions).
However, note that given the complexity of large pharma org structures, solutions may require policy changes and multiple stakeholders and discussions. This requires patience from the intrapreneurs and change agents driving these initiatives. However, once achieved, their impact will be large.
High volume of processes
People who’ve built their careers in large pharma rarely encounter an SOP they haven’t met. This is for a few reasons.
Because large pharmas are well known, and therefore highly publicly visible, their corporate governance is scrutinized by all. This means that they need to show and ensure compliance with laws and guidance. One way to do is through SOPs, Work Instructions, and checklists.
Another reason is that processes allow companies to scale. Without SOPs, large pharmas could never have reached their current size. It would be impossible to manage such a large number of personnel and activities without standardized guidance.
Unfortunately, reading and executing numerous SOPs is time consuming for employees, especially since large pharma SOPs are long and detailed. Further, so many activities require checklists and multiple approvals. In fact, for experienced employees who have also worked at small pharma, it can seem easier to just jump in and do work instead of having to hew to existing instructions.
The solution:
- At the organization level, for the reasons stated above, numerous SOPs and other document types are required and can’t be worked around.
- However, clinical operations SOPs should be reviewed annually and updated accordingly.
- Most companies already have a process for this; however part of the review should include determining if any processes or documents can be streamlined or consolidated.
- At the employee level, we recommend the following:
- During an employee’s initial company onboarding, the employee should skim all the SOPs assigned to them in the learning management system (LMS) or e-TMF.
- During this initial review, which is more to understand which SOPs and processes exist, employees should pull out and save to a personal folder, those documents that will govern their work directly. In this way, they can retain easy access to them when they need to read them in more detail before or during enacting a process.
- However, during their tenure at the company, the company will release new SOPs or ones that supersede previous versions. They should ensure that these replace old SOPs in their personal drive.
- In rare instances, some document (mainly forms) are required to be pulled directly from their official home (LMS or e-TMF usually) in real-time. In these cases, the employee should make a note to pull them directly from the source.
High number of systems
Companies across the board experience this classic large pharma paint point in clin ops.
Large pharma’s deep pockets allow them to deploy numerous systems – external and homegrown. One would think that having access to so much technology would make employees’ lives easier. However, it paradoxically results in more work and complexity for teams.
Think of it like this. Technology wise, most small pharmas only use:
- Spreadsheets, EDC, and IRT
- Or, one clinical trial platform, EDC and IRT
Whereas a large pharma could use:
- Spreadsheets
- CTMS
- EDC
- IRB
- Clinical analytics software
- Centralized monitoring software
- Risk management software
- Homegrown ICF generator
This requires clin ops teams to navigate to various systems to do their work and can even increase the amount of required manual data entry. Further, some of these systems are integrated with complicated automations that alone are governed by numerous SOPs (see applicable section below).
So, the work of clinical operations becomes more about managing and understanding various technologies than focusing on key activities that drive the trial forward.
And we haven’t even mentioned the additional systems that are acquired after the pharma company acquires smaller companies.
The solution:
- Note that here, it’s very important to include all relevant stakeholders. Sometimes these groups aren’t in communication with or aligned at all. However, it’s very important for these cross-functional meetings to happen, especially when certain groups manage some systems and not others (business operations vs IT vs analytics).
- Head of business groups using the system(s)
- A few tech-savvy end user representatives from these groups (we can’t stress enough how important they are)
- Business operations
- Clinical systems
- IT/Analytics
- Business operations
- Procurement
- Re-evaluate the entire clinical operations tech ecosystem via this process:
- List all disparate systems and whether they are homegrown or external
- Next to each system, list the following after soliciting input from all the stakeholders:
- Category of system (Example: CTMS)
- Vendor and name of system (Example: Global Solutions TrialReady)
- If the system is internal or external (Example: external)
- Its purpose, and if it’s being met (Purpose: to consolidate trial information and make it easier to access by senior leadership and study teams. System has made it easier to access trial information by both groups over spreadsheets; however system design is clunky so information is still time consuming to filter for and the study team is still reliant on creating and maintaining spreadsheets to supplement the system)
- Its ROI in terms of time or money saved, and if that is being achieved: (Example: Marginal time has been saved over the use of spreadsheets only)
- If the system has overlapping functions with one or more other systems and if so, by what percentage (Example: Functions overlap with spreadsheets and clinical dashboard, 25%)
- If the purpose and/or ROI are not being met, and/or the system has lots of overlapping functions with other systems, then flag that system for re-evaluation and future consolidation
- Some companies do this annually or regularly anyway, in the form of sending RFIs to alternative vendors to assess their capabilities against the incumbent.
- When evaluating new systems, prioritize those that streamline and lower work instead of adding complexity and have the potential to become yet another silo. However, note that many platforms that try to “do it all” don’t end up doing anything well, so balance your consideration with that.
Over automation
Above, we mentioned the numerous systems used by large pharma, and how some are integrated with complicated automations that are described by numerous SOPs.
A few examples:
- A two-way integration between CTMS and IRT
- A one-way integration between IRT and EDC
- A one-way integration between EDC and an analytics dashboard
Above in this article, we already mentioned how fielding numerous SOPs is time consuming for employees, so we won’t expand on that here. However, it is another consequence of over automation.
Here again, the work of clinical operations becomes more about managing and understanding various technologies than focusing on key activities that drive the trial forward.
The solution:
- Follow the steps outlined in the solution for “High Number of Systems”, but for each automation instead.
- Also, determine if the automation adds more effort and complexity than just having the process done manually.
High employee turnover
This large pharma pain point in clin ops usually flies below the radar.
Granted, any company can have high employee turnover. Poor culture, instability, and stagnant compensation can exist at any company. However, as a rule, larger companies have higher turnover, across all industries.
In the long-term, this may not necessarily be a bad thing. However, in the short-term, it’s a headache for study teams and their leadership. Related problems:
- Employees switching from one study to another have to re-train on an entirely new (frequently complicated) trial protocol and related processes
- Existing employees may need to cover for suddenly departed teammates, leading to an increase in their workload, subsequent burnout, and possibly their own turnover
- Critical team members who depart may leave with key, nuanced knowledge that is not a part of the transition training for their replacement. If they depart with little notice, than a proper transition may not occur at all.
- This may lead to key activities and milestones falling through or needing to be re-tread, preventing the smooth continuation of the trial
- Too much turnover can prevent the establishment of positive team culture.
- This is because team members can become reluctant to invest too much time into relationships that they know may not last long.
The solution:
Knowing that high turnover is a reality, large pharmas should be ready to make transitions as smooth as possible. The best way to do is by creating a standard study onboarding process. At a minimum, the process should include:
- Introduction of the new team member to all study stakeholders that they will interact with, and a request to include them in all relevant meetings and communications
- Review of the study team (including vendors and if applicable, CRO)
- Protocol training
- Study history, overview, and status review
- Timeline review
- Responsibilities review
- Tools, documents, shared drive, and pertinent systems review
Poor quality preferred vendors
Unlike at small pharmas, large companies usually work with the same vendors and systems repeatedly, i.e. “preferred vendors”. These vendors can be so embedded in the company’s functions that the company has written a suite of vendor-specific SOPs or frequently refers to the vendor in other SOPs.
This can be great for fostering deep relationships, mutual understanding, and at times, efficiency. However, it can also lead to vendor complacency and/or the vendor leadership or service quality changing overall, resulting in poor services to the large pharma client. If this happens, then the study teams can’t easily change vendors mid-study, if at all.
The solution:
- Maintain a larger suite of vetted, preferred vendors (5-7) and ensure that all vendors know this, to maintain motivation and quality
- For quality issues on a single study or program, request that the vendor assign a different project director and/or team
- Start an escalation pathway with the problem vendor (similar to that described in our small pharma pain points article):
- Raise the situation to the vendor’s leadership (preferably using the highest level of company clinical leadership available)
- Define and set service quality benchmarks to be met by a deadline
- Then, if all else fails, change vendors and/or cease use of the vendor permanently
In this article, we dove into large pharma pain points in clin ops. As you can see, some pain points relate to each other and have mutual solutions.
At Seascape Clinical, we know this well. That’s why we designed our all-in-one clinical operations automation tech solution, ClinOps Pro, to simplify and speed large pharma teams’ work by automating and streamlining their trial work and oversight. This allows large pharma companies to leave their pain points behind and focus on being the powerful drivers of the industry that they aspire to be.
