The Midwest region has seen a big rise in small biotechs in recent years. Significantly, the importance of being successful has never been greater, especially given the strong presence of big pharma companies in the region. The opportunity for success remains very much available for all small biotechs to grab with both hands. With the majority of companies outsourcing their clinical trials, ensuring you have a simple, efficient and joint plan remains the key to achieving success.
Finding a route to success for biotechs is developed over time and by overcoming mistakes. Here are some of the key aspects biotechs need to improve upon:
As mentioned previously, many smaller biotechs choose to outsource their clinical trials to CROs simply because they don’t have the resources to complete the trial themselves. Selecting the right CRO can often be one of the biggest stumbling blocks for biotechs and this is mainly because the financial restraints they work with forces them to pick a CRO which can do the job within budget. This might not always be the best CRO for the company or one which provides the best quality. Considerations biotechs should regard when choosing their vendor are:
- Expertise in chosen therapeutic area
- Flexibility of CRO plans
- Ability to execute plans efficiently
- Access to patient pools
Getting the right attention from your CRO to achieve clinical trial success
One of the challenges biotechs often face is receiving the attention they require to ensure their clinical trials run smoothly. CROs can sometimes be found at fault for spending more of their time and resources on some of the larger sized pharma companies. This is mainly because they are receiving more money from those companies, therefore the CRO will feel more invested into the final outcome. Whilst this may be wrong and many people will argue that everyone should receive the same standard of service, unfortunately this isn’t always the case. So how does a biotech ensure its money and clinical trial receives the attention it deserves?
- When initially selecting a CRO, it is imperative to choose one which is aware of the structure of your company
- Work with your vendor to establish the key goals and needs of your company to help avoid misprioritisation
- Establish a resource plan and agree on set timelines
- Ensure regular reports are exchanged between both parties (site initiation reports, patient enrollment reports, etc.)
Overcoming issues with resources
For a number of small biotechs, staff resources can often be limited with most companies consisting of 5-15 people. Also quite significantly, a lot of the staff will be heavily focused on the development of the drug compound so many will have little clinical expertise. As a result, many aspects of the clinical trials are outsourced. But with some smaller companies not having the financial capability to fully outsource, therefore establishing what to outsource and when is essential. With a limited budget, the internal team needs to review carefully what it can do to get the best out of its team as outsourcing unnecessarily can often be one of the biggest pitfalls for most companies. Having said that, by using untrained staff for tasks such as monitoring can be detrimental to your study as it can affect the quality of the data received if not done correctly. Here are some key things to consider to help with issues over limited resourcing:
- Establish the key areas in which outsourcing is absolutely necessary by outlining tasks which require further expertise
- Adopt a collaborative approach in which a resource plan is constructed in which your internal team can be supported by your vendor
Establishing strong relationships to help increase efficiencies
One of the key pillars for every successful partnership between sponsors and CROs is the need for a robust and strong relationship to allow for productive trial service. In order for clinical trials to be efficient and successful, productive communication is a pivotal factor. Other important factors include are:
- Arranging regular meetings to ensure tasks are completed on time and that the goals of both sponsor and vendor are aligned.
- Establishing accountability with key leaders to ensure deliverables are met and delays do not occur
- Clear designation of responsibilities to help avoid missed tasks
- Creating a site by site management plan to meet the needs of each site
It can be very difficult for small biotechs to achieve clinical trial success given the restrictions they are forced to work under. Nevertheless, the rewards can be huge. Therefore, it is imperative to have correct procedures in place to support internal resources and, most importantly, find a CRO that can not only provide the best quality service, but is fully invested in your clinical trial.