Expert offers tips to improve operations

Expert offers tips to improve operations

Here are four best practices

Before a sponsor company, a research institution, or a clinical trial site expands and grows, managers should think clearly about the organization's culture and plan accordingly, an expert advises.

"One of the things that smart companies do is think clearly about what their organization's culture is before they make a decision about how big the clinical operations will be," says Laurie Halloran, MS, CCRA, president and chief executive officer of Halloran Consulting Group of Brighton, MA.

"What I see as progressive companies are those starting to think about the business, versus just the science, as an important aspect of clinical operations," Halloran says.

The companies that gain the biggest benefit from clinical operations are those that have a primary focus and vision on high quality and efficiency, she adds.

For instance, pharmaceutical companies historically have been therapeutically oriented with isolated teams working on one disease entity, Halloran explains.

"There was little cross-fertilization between teams," she says."Now, they're realizing they need to think horizontally and not act like 10 different small companies where nobody ever talks to each other."

Halloran offers these best practice suggestions for implementing such a change:

1. Show support from the organization's top managers.

This type of philosophical change requires support from top management for a process of mandating quality, training for quality, building an infrastructure for quality, and encouraging cross-department communication, Halloran says.

Academic research organizations, like the traditional pharmaceutical company, could also benefit from this type of philosophical change, she says.

"Scientists are not trained or encouraged to work collaboratively, but are trained to experiment independently," Halloran says.

Collaboration between departments is a very different philosophy than the individual experimentation habit, and it means that an institution would need to embrace business practice, including program management, cross-functional processes, and top-down supported training, she says.

"So the number-one best practice is to foster and support from the top an operations function that centrally ensures quality, as well as efficiency," Halloran says.

2. Make the most of the regulations' broad application.

"I steal the quote, 'Skating the gray,'" Halloran says."Regulations are very black and white, but they're also very broad."

The research industry has gotten bogged down in thinking it can write up a process or procedure that interprets every single situation; it doesn't work, Halloran says.

"People get stuck and are drowning in the process," Halloran says."What 'skating the gray' really means is an organizational adoption of principles of critical thinking, problem-solving, and training of those skills."

The goal is to interpret regulations to fit a situation while still remaining true to the practices and regulatory intent.

For example, a compliance auditor comes up with findings in an audit that are applicable only in specialized circumstances, Halloran says.

"Rather than training the team how to think through the business and regulatory impacts of the issues, the compliance department rewrites the standard operating procedures (SOP) to cover the remote likelihood of this incident happening again," she explains."The outcome of this is that people either continue in a noncompliant way or they drown in the process."

The problem is that many people working in a research organization do not know what the regulations actually say, Halloran says.

"They think, 'We've always done it this way, and so it must be in the regs,'" she says."One person told me, 'We have to write in the third person because it's in the regs.'"

Federal regulatory officials often say at national meetings that"less may be more," meaning that research organizations should look at what the situation is and analyze where it could impact patient safety or data quality, Halloran says.

"They should document where those issues have been dealt with and not create 1,000 pieces of paper just because everything has to be written down," she adds."You have to apply wisdom to problem solving."

Too few people have those skills, and they're so concerned they will make a mistake that they take compliance beyond what is necessary, Halloran says.

"This causes compliance departments to say, 'If we cover every eventuality in the SOPs then people will follow it,'" Halloran says."But it doesn't work that way, so the business strangles under the weight of cumbersome SOPs."

3. Keep it simple.

"Another best practice is to keep documentation simple and to teach problem-solving, and hire with an eye toward the wisdom that comes from experience," Halloran suggests."Don't make the SOPs a substitute for training and knowledge."

For example, an organization's SOPs might include this line:"A monitor must document all communications, including email, faxes, and letters," Halloran says.

"Just the fact that it says you must document all communications exponentially increases the paperwork," Halloran says."But if youchanged it to say, 'A monitor must document all significant communications,' it simplifies it dramatically."

The key is that staff must be trained to understand what"significantly" means in this context.

"The people writing SOPs write them more complex because it's a quick fix in their minds," Halloran says."They think that if you write a 35-page SOP then people have to follow it — but it doesn't have to be this complex."

4. Plan ahead instead of reacting.

"Very few organizations ever are given the luxury of having time to plan," Halloran says."This is very closely interwoven with not knowing what happens from above."

Many organizations react rather than being proactive due to a lack of top-down communication that is clear, concise, and complete, Halloran notes.

"There's a general perception among the avenues I travel that information is withheld from management and staff levels of organizations because there's a lack of understanding about how much the big picture would help them in their planning," Halloran says.

"We all run around so busy and so frantic that we lose the benefits planning would give us to rest and reflect while we consider the best practices that we can adopt," Halloran says.

Planning includes two important elements regarding staffing an organization:

• Make sure you have the right people in the seats on the bus, Halloran says.

"A lot of people make the mistake of needing a body to fill a spot and then settling for a person who kind of meets the criteria," she says."Then they're always suffering because of that choice, and this is true of virtually every organization I know — there are people who should never have been put in the positions they're in."

This is the essence of the saying that bureaucracy is created for the purpose of dealing with incompetence, Halloran adds.

The key is to hire people who have the ability to solve problems, communicate well, and be flexible and proactive, Halloran says.

These qualities should be a higher priority than the technical skills, because those skills are more difficult to teach staff, she says.

"But then you have to invest in the training," she notes.

• Training is essential, Halloran says.

"Some people think training should be a luxury instead of a necessity," Halloran says."But no matter what level a person is in, ignorance is much more expensive than education, and that's from a Chinese fortune cookie."

Organizations try to contain costs, and so managers decide to cut training first without regard for the overall organizational impact of that decision, Halloran says.

"Some organizations are adopting technology that has some value, but it will never replace what a live educational program does to give richness and group wisdom to an organization," Halloran says."It's, overall, a short-term gain financially, but a long-term loss organizationally."