Effective management of your clinical trial budget

Clinical Trial Services

Successfully executing a clinical trial is a large undertaking that requires strategic planning and cooperation. Even if you have appropriate staff, it is often necessary to hire a contract research organization (CRO) to help share the workload. A CRO is a company that provides clinical trial services for the pharmaceutical, biotechnology, and medical device industries. There are different types of CROs, but typical CRO services in the medical device industry include regulatory affairs, clinical trial planning, site selection and initiation (including contracting and budgeting), patient recruitment support, clinical monitoring, data management, trial logistics, biostatistics, medical writing, and project management. CROs have the knowledge, capabilities, processes and procedures that are needed to develop and run a successful clinical trial, while ensuring trial quality and compliance with national and international standards. Working with a CRO can provide access to innovative tools that can increase efficiencies, leading to shorter timelines and decreased cost.

Choosing the right CRO

While there are several factors you need to consider before hiring a CRO, it is important to do your homework and involve the right people in the process. Choosing the right CRO to run your clinical trial is crucial to the trial’s success. In addition to consideration of their own project needs, requirements, and budget , Sponsors should evaluate the quality system processes, qualification, and experience of the CRO.  It is ideal to find a CRO with experience in the particular product type and therapeutic area of interest, but as important is to find a CRO with the knowledge and experience to apply the appropriate regulations and international standards and to tailor the project to the specific needs of your product development and company goals. Ask yourself whether the candidate CRO is listening to your needs and has the flexibility to create a customized program to meet those needs in an efficient and cost-effective way, or if they are just trying to fit your project into their clinical trial machine.  Will they be attentive and devote resources even on smaller projects?  For the best chance at success (and the best experience), the CRO must be proactive and responsive.  They must identify any potential study issues and have the ability to course correct and implement changes quickly, and the project team must be available to answer questions and provide updates as promptly and often as desired.

After you’ve selected the right CRO, you’ll need a well-defined study design and protocol before you can really dig into costs and budgeting. It is important to understand that these are initial estimates and will need to be adjusted once key study documents are finalized. Additional information you should already have sorted out within your team are:

• Protocol design
• Risk analysis and mitigation strategies
• Outline of the proposed scope of work
• Plan for managing study responsibilities

What to expect when budgeting for a CRO

The first thing you can expect is that running a successful trial will not be cheap. A good CRO can help you determine ways to control the expenses, helping you to achieve your goals in a cost effective and time saving way. As there are many cost variables to consider, here are just a few:

• Type of study
• Complexity of study
• Number of sites and location
• Type of device or therapy
• Services needed
• Training
• Electronic data capture
• Site startup costs
• IRB fees
• Meeting costs
• Auditing and monitoring

Reasons your budget could get off track

Even when considering these costs, there will always be unforeseen study changes that can have an impact on your study budget. An experienced CRO will know what to expect and can help you avoid potential budget hurdles. Your team should be comfortable asking CROs up front how they handle budgeting challenges. From our experience, a few of the biggest challenges in clinical trials that cause budgeting problems are:

• Delays
  Enrollment delays, site start up delays, or product availability can increase the time and cost of running the trial.
• Adding to the project scope
  Be careful not to unintentionally add to the scope of the project when you are working closely with your CRO.
• Managing travel to sites
  Travel expenses can add up quickly when you are managing multiple sites. Your CRO can help you determine which study tasks can be done remotely and which are essential to do on-site.
• Turnover
  Unfortunately, turnover can occur within your internal team, at your study sites, or with your vendors. When selecting a CRO, it is important to discuss their turnover rate and how that is handled within the organization.

Our clinical trial services

Selecting the right CRO to support your clinical trial is critical to a successful outcome. With over 35 years of experience, our clinical trial team has the knowledge and skills to be your trusted partner. We treat every project like our own and are dedicated to keeping your clinical trial budget on track. Please contact us today if you have any questions or to start the discussion about your clinical trial needs 855.463.1633 | askmed@medinstitute.com | medinstitute.com.