Jeff Souza

Pharmaceutical start-ups understand the importance of conducting a strategic clinical development process, but few understand how to mitigate the risks inherent in the process without incurring exorbitant costs. The biggest mistake that many companies make is committing to hire permanent staff upfront, a decision that can quickly burn through cash and force founders to trust unverified experts with the future of their treatment.

To effectively position themselves for success without breaking the bank, pharmaceutical start-ups should assess what therapeutic expertise they require, assemble a team of trusted consultants to fulfill those needs, then analyze their clinical roadmap to determine when and for how long each expert should be engaged as trials commence.

Pharmaceutical start-ups require a wide breadth of expertise to ensure clinical trials are properly conducted. The last thing any founder wants is a failed submission to FDA, which would considerably impact their ability to raise money from investors in the future, but few start-ups can afford to hire an expansive staff to prevent that.

With limited resources, start-ups should begin their clinical trial roadmap by assessing what therapeutic expertise they require. This assessment should be conducted in a tiered approach, from basic science down to medical specialties and interdisciplinary fields. A tiered assessment will ensure a smoother search for consultants, as it is easier to find individuals within broad fields before narrowing the search to unique specialties.

Once management has a clear, tiered understanding of required expertise, they can begin a more strategic search for the right consultants.

Instead of the costly, high-risk route of paying a staffing agency to recruit permanent employees, pharmaceutical start-ups should engage a medical group that understands the industry and can provide access to trusted clinical experts. An example of a group that start-ups could engage is a contract research organization (CRO), which provides start-ups with a range of services to handle the entire clinical trial process from start to finish.

The downside to working with a CRO is the high cost of engaging one. They often have minimum spends that their clients must commit to a project, and there are strict timelines for conducting projects that may not align with a start-up’s needs. The alternative to a CRO is an emerging category of organizations, one that specialize in clinical development services. These service providers act more like an independent advisor that can be as involved or hands-off as a company desires. The most effective clinical development service providers will have access to all-inclusive teams that can bring in various experts, from physician researchers to regulatory affairs specialists. This type of partner provides a team that acts like full-time employees without the commitment to hiring permanent staff.

Once a team has been assembled, the start-up must determine when to engage each its new roster of trusted experts.

Pharmaceutical start-ups may feel the urge to engage each consultant at every trial stage. After all, it sounds easy to minimize risk by ensuring every expert weighs in during a project. However, start-ups must remember that their newly assembled team is not a group of permanent employees. When building out a clinical trial roadmap, companies should include specific plans for how and when each consultant will be engaged, and more importantly, how much they should allot to pay each consultant for their services.

This is where partnering with a clinical development service provider can be invaluable. A reliable partner will have extensive experience in managing clinical trials from beginning to end, and with that experience comes time efficiency, or an understanding of when various experts will be needed at each stage.

In addition to staffing, many start-ups do not consider the expertise needed to properly manage the vendors required to conduct clinical trials. Partnering with a clinical development service provider can help on this front, too. The right partner will take the initiative and serve as an advocate for the start-up, engaging its vendors and offering guidance that helps the company meet its business goals.

By drawing out a roadmap that accounts for consultant engagement, start-ups will be well-positioned to ensure a smooth process for completing clinical trials on time and on budget.

Going the consultant route to complete clinical trials may not be the grand vision that founders have for their start-ups, but it is a cost-effective and low-risk approach that will streamline a treatment’s path to market and maximize a company’s good standing with potential investors to secure future funding.

Articles

How pharmaceutical start-ups can mitigate risk and avoid costly hiring mistakes.

Jeff Souza

Articles

Alternatives to Permanent Employees