So you've decided to hire a contract manufacturing organization (CMO) to produce your clinical-trial materials (CTM). Or you've just signed a deal to provide your services to a top-tier pharmaceutical company. But how do you ensure that the project goes smoothly? Which factors will guarantee that the job is completed successfully? CMOs, pharmaceutical companies, and consultants offered Pharmaceutical Technology some interesting answers.
All sides agree that accurate and timely communication is a big requirement for a successful outsourcing relationship. "Transparency is key in building good information flow," according to Scott Houlton, chief operating officer of Aptuit (Greenwich, CT), a contract drug-development services company. Partners must be readily available to answer questions and offer details about the work at hand. This way, CMOs are sure to understand the project's specifications, and pharmaceutical companies will know about problems that arise.
"Another key," Houlton adds, "is to have consistent, ongoing work so that the communication stays fresh." Sharing one major project or many small projects forces sponsors and clients to exchange information regularly. Regular contact helps both parties achieve goals and keeps everyone updated about the project's status.In addition, a successful outsourcing partnership requires a great deal of strategic planning, according to Nailesh Bhatt, managing director of the consulting and advisory firm Proximare (Princeton, NJ). Outsourcing relationships are evolving to the point that pharmaceutical companies are "actually talking about tactical strategies with each of the partners," Bhatt comments. Companies are "getting extremely granular," he continues. They might ask a CMO whether it would manufacture their product locally or overseas. They could ask how the CMO's strategy will affect timelines, cost, and product quality. Suppliers are realizing that they must have answers for these questions, Bhatt observes.
Houlton agrees that partners must join to develop a strategy for the project. They should spend time "planning for success rather than reacting to last-minute changes," he says.
Maureen Spataro, founder and president of the consulting firm Spataro and Associates (Wilmington, NC), specifies the kind of planning that contractors and their clients must perform. She says the parties should establish master agreements that detail the "clearly defined deliverables" for which the provider and sponsor are responsible.
A plan must also incorporate realistic timelines that both sides agree to, Spataro continues. Establishing deadlines and sticking to them is crucial, as Anthony Moult, director of global clinical-trials supplies at UCB Pharm (Braine-l'Alleud, Belgium), emphasizes. "We might be happy with a CMO," he remarks, "but if they can't meet our timelines, we go elsewhere."
But possibly the most important (and most obvious) factor in a positive outsourcing relationship is cooperation. CMOs and pharmaceutical companies must build "cooperative relationships" for their projects to be realized successfully, according to Bhatt. "A great deal of collaboration and a lot of back and forth are involved. It's a consultative approach," he explains.
"Both parties should have a mutual investment in the success of the relationship," Houlton adds. Spataro echoes this sentiment by noting that each party must meet its commitments. "If either party has too much of the influence," Houlton says, "then the relationship suffers." When an outsourcing relationship has a foundation of trust, he continues, work can proceed efficiently because the sponsor will have less need to verify the outsourcing partner's work.
For more on this topic, see "Outsourcing Clinical-Trial Materials Heats Up"