From The Editor | December 19, 2013

WIB Profile: Cutting The Length, Cost, And Complexity Of Clinical Trials

By Ed Miseta, Chief Editor, Clinical Leader

Sophie McCallum has spent almost four years with clinical solutions firm ClinCapture, currently serving as its director of operations. In this position, McCallum oversees and manages the marketing, HR, finance, and inside sales departments. She also works with the governance team to plan and implement corporate vision and strategy, develops strategic plans and direction for products and services, develops tools and controls to track company profit margins and department budgets, and analyzes business and operation procedures to increase company efficiency and worker productivity. In this Women In Bio profile, McCallum discusses her role in helping build the company, and trends she sees occurring in the clinical research space.

1. What do you believe is the biggest trend impacting firms that do clinical research?

Sophie McCallum, director of operations, ClinCapture

Despite the growth rates in our industry, there are a number of trends making clinical research more lengthy, costly, and complex. One is increased regulatory requirements, especially relating to data collection. Personalized medicine, biomarkers and orphan drugs are setting the trends for smaller and faster clinical trials with accelerated approval pathways. However, the overall complexity of clinical trials has been on the rise, as regulatory bodies are requiring larger amounts of data to provide evidence of a drug’s safety and efficacy. This implies more endpoints and analysis, ever more-challenging protocols, and increasing numbers of patients per program needed. Thus sponsor companies need to face high patient recruitment costs and handle more data – and paper – than they ever used to. This is driving the cost of clinical research significantly higher.

At the same time, there has been growing pressure to reduce the cost of clinical research. Clinical research is one of the most expensive areas of drug development. Research has shown that bringing a new drug from initial formulation to a patient can take over 13 years and cost $1.3 billion. Industry data also shows that clinical trial costs are growing across all development phases.

Conversely, the current patent cliff will create an estimated $250B in lost sales for the industry by 2015. Revenues are also affected by regulatory reforms such as the Sequester, a package of automatic spending cuts projected to total $1.2 trillion between 2013 and 2021. This could force the FDA to slash jobs and thus lose some of its capacity to approve drugs. Finally, personalized medicine reduces the size of the patient population for whom the drug is intended and, therefore, the revenue potential.

As a result, pharmaceutical and medical device companies are under growing pressure to reduce clinical development costs while simultaneously being required to conduct more complex clinical trials. This creates an imbalance between resources and requirements that must be addressed.

2. How is this trend affecting the drug sponsors who are outsourcing their research?

To face these challenges, sponsor companies have been collaborating more than ever with CROs, who in turn have been investing money and time in developing tools and methods that bring the cost of clinical research down. One example of these collaborations is the FSP (Functional Service Provider) model. FSP is a resourcing model that gives sponsors access to a wide pool of experienced, thoroughly trained resources through their CRO. This offers sponsor companies the ability to rapidly scale up or down as their needs arise. This model also minimizes their management overhead and takes away the burden of building a team from the ground up. It has been argued that the FSP model can bring sponsor companies savings of 20% in time and 40% in costs.

Another collaboration example is the development of new cloud-based and cost-efficient eClinical systems. eClinical systems providers and CROs are significantly driving down the cost of clinical data collection, management and analysis while meeting regulatory FDA requirements by leveraging new standards and cutting-edge technologies. Some good examples are: Comprehend Clinical (a SaaS reporting tool), Gobalto (a cloud-based site initiation solution), and ClinCapture (open source electronic data capture (EDC) system. These new solutions allow smaller companies to afford high-end technology, allowing for significant time-savings, improved data quality, and cost-savings. As an example, a sponsor company calculated they reduced the duration of their clinical development by up to 30% using an EDC system as opposed to paper. They were able to leverage the benefit of single data entry, remote monitoring, and a huge reduction in the number of queries.

3. How do you feel smaller companies can best compete in this space with competitors that might be much larger or that have been around a lot longer?

In my role, I have the opportunity to talk a lot to our clients and prospects and this gives me an insight in to what drives them to small to mid-size companies. Sponsors will choose to work with a smaller CRO for a number of reasons, but I am proud to say that over 89% of our clients are repeat customers that have said they would not think of contracting with a larger CRO. 

They will generally emphasize the same benefits of working with small, nimble CROs, such as:

  • The flexibility of the team who goes the extra mile to adapt solutions or customize systems to their specific needs on time and budget.
  • The personal attention and team responsiveness at all levels of the organization really makes them feel like we are listening to them. Excellent customer service is one of the core values for all smaller CROs, whatever the size or budget of the client.
  • Smaller companies are capable of offering solutions at up to a quarter of the price of proprietary market leaders. 

4. What it was like for you and your team to build this company from scratch?

When I joined ClinCapture, my role was to build the brand from the ground up, implement the marketing and communication strategy, and launch lead generation initiatives to bring in clients. My role was also to help the executive team (CEO Ale Gicqueau, CTO Marc Desgrousilliers, and senior director of staffing Trisha Heredia) to structure the company; from recruiting and managing new teams, to articulating a service offering that fit our clients’ needs, and putting in place strong company values and principles.  

Building a brand, and company, is an exciting challenge. You need to wear multiple hats, whatever your role, background, or level of responsibility. You need to recruit the right talent that complements your skillset. You need to work hard and then you need to work even harder. The key to success is passion, focus and patience.

But there is nothing more inspiring to me than building a team, seeing it grow with the company, and witnessing its achievements first hand, from that initial customer to the release of a new product.

5. How is Women In Bio (WIB) helping you and other women become industry leaders in the clinical space?

I think Women In Bio differentiates itself from other organization for several reasons. It is composed of passionate, successful women. I have found true mentors at WIB who continually guide and help me in my career. By talking and listening to experienced women in leadership roles, I learn how to act and work in the corporate world to better grow. I am always inspired by the achievements and dedication of the women in WIB.

By giving members the opportunity to work together in growing the organization, WIB also builds an in-depth relationship with members and a higher quality network.

WIB also has a number of quality programs in place. These programs bring a lot of knowledge that proves useful both in the clinical space and in the management and advancement of your career. The passion of these women for the industry is truly contagious.