Getting the Match Right

Not so long ago, companies hired consultants exclusively for their specialized expertise, to answer thorny questions or to solve tough problems. The consultants I knew in that era wore dark suits and proffered expert advice in paneled conference rooms in exchange for astronomical bill rates. Today's consulting landscape looks vastly different, with companies engaging consultants on short-term and long-term projects to provide support with a surprising variety of everyday services. Virtual biopharmaceutical companies frequently operate with a lean core staff and an army of consultants and service providers; other companies hire consultants to help maintain timelines during spikes in their workload or to fill gaps caused by employee attrition or medical leave. Consultants have traded in dark suits and conference rooms for khakis and cubicles. As the lines between employees and consultants blur, it is clear consultants are becoming an increasingly indispensable and strategic part of our workforce.

For all the good they do, the uptick in consultants hanging out shingles correlates with an increase in risk for potential pitfalls and problems. Mismatches of technical expertise, bill rates or even personalities subsequently can result in missed milestones and increased regulatory scrutiny and patient risk. Recognizing consultants are not one-size-fits-all, clients who develop a framework to screen potential consultants before working together enjoy a greater likelihood of success later. After working with hundreds of consultants, my company developed a simple matching process called PEARL™ (personality, experience, availability, rate, location).

Personality

Consider whether you need a detail-oriented expert to review reams of data or a strong leader to facilitate strategic planning sessions. It is essential for the consulting firm to weigh your input to know when to suggest a strong extrovert or a detailed analyst, or someone in between.

Questions to ask yourself include:

• Am I asking the consultant to mediate between two parties who do not always work together well? Will the consultant need to navigate internal politics?
• Will the consultant spend most of his or her time reviewing documents and data or will the consultant spend most of his or her time in meetings?

Experience

Be as specific as possible about what you consider to be an ideal technical background to address your needs. For example, if you are seeking support in preparing a 510k for a device, it probably is not a good fit if a consultant has only worked in quality control testing tablets and capsules.

Questions to ask yourself include:

• What one skill or prior technical experience would be most helpful for a consultant to succeed in our company?
• What related skills might be transferrable, even if not a direct match, for success on this project?

Availability

Be clear about how much time you anticipate needing. Needing 40 hours a week or 40 hours a year could eliminate otherwise-eligible consultants from consideration immediately, but could be a perfect new opportunity for a busy consultant with otherwise restricted availability due to childcare or other constraints.

Questions to ask include:

• Could two different part-time consultants achieve my goals?
• Do our projects require a consistent level of consulting support or does the workload ebb and flow?

Rate

If a bill rate sounds too high (or too low), ask colleagues for a sanity check before pushing back on the consulting firm. Consulting firms must factor in your budget to select a consultant at the right level.

Questions to consider include:

• Am I willing to spend some time training a junior consultant to save on the bill rate?
• On the flip side, is an expensive, top-level senior consultant overkill for the scope of work?

Location

Virtual clients increasingly prefer that consultants work remotely. This flexibility opens up a pool of talent around the world; conversely, needs for on-site consultants restrict the number of eligible consultants. If you know you need on-site support, consider a firm with the strongest presence in your specific geographic area rather than the firm with the biggest national presence.

Questions to ask include:

Are there any tasks that could be performed off site? For example, would I be open to a consultant working on site six hours each day and remotely for two hours so they can avoid peak rush hour traffic?

Past Experiences

In 2007, we suggested a specific consultant to a client. She initially was asked to review batch records, which she loved to do and at which she excelled. After a few days on the project, the client shifted gears and asked her to write several Standard Operating Procedures (SOPs), which initially seemed like a great idea. However, the first SOP involved getting the head of clinical and the head of quality to meet and agree on the SOP content; these two individuals did not respect each other and the consultant was caught in their crossfire. The SOP that she drafted met a predictable fate; both sides dug in their heels and she simply was not able to mediate between the two departments. The consultant was frustrated and the client terminated her project prematurely. The change in scope demonstrated that, while the consultant was an expert reviewer, she was unskilled at navigating political situations. This situation led us to add the "P" to PEARL.

On another occasion, a client needed a consultant to review a sizable backlog of stability data and create a detailed summary spreadsheet. We suggested an extremely capable analytical data reviewer who was also a shy introvert. The client initially rejected the consultant based on his interview skills (he was very quiet and answered all questions with a "yes/no" response), but we encouraged the client to give him a try because we knew his technical abilities from prior experience with him. In the end, the consultant's stability spreadsheet was "perfect" and he also warmed up to the client; that client later wrote a glowing testimonial about him. As important as personality is, there is no substitute for the right experience.

In some instances, we offer a 'tag team' approach with multiple part-time consultants to tackle what was initially considered a one-person job. Although this approach is more complicated to design and manage, it is helpful when clients are open to think creatively when their requirements cannot be met by an individual consultant. Today's technology makes it easier than ever for remote consultants to contribute to a project's success.

Final Thoughts

A well-matched consultant can be a wonderful asset and partner, but a square peg misfit conversely creates endless headaches and timeline delays. Time spent by life sciences companies up front on consultant screening and matching has the potential to yield greater project success down the road.

About the Author

Jonathan Morse, RAC, is the principal consultant at Complya Consulting Group, which offers regulatory and quality consulting services for biopharmaceutical and device clients. Morse has expertise auditing international CMOs and providing Phase 1-3 quality oversight for numerous start-up companies. He can be reached at [email protected].

Cite as: Morse J. "Getting the Match Right." Regulatory Focus. May 2014. Regulatory Affairs Professionals Society.