Best Feasibility CROs
Feasibility assessments rarely handle the large budgets of a full-scale trial and don’t require the kind of long-term commitment of one. Yet, they can play a vital role in the future’s trial chances of success.
Perhaps the most considerable challenge for feasibility studies is the necessity of speaking in hypotheticals. When performing a feasibility study, a CRO often draws on its past projects or those of the consultants it recruits. These experiences, combined with updated knowledge of a specific process, are then used to guide an upcoming trial.
There are three main types of Feasibility studies:
- Program level assessments, which look at a long-term initiative or program as a whole
- Study level assessments, which look at a particular study and its protocol
- Site or investigator level assessments, which will look only at a specific aspect within a study.
Any of these three levels can focus on ethical, regulatory, medical, or logistical aspects – or a combination of them all.
Why Engage a Feasibility CRO?
Feasibility studies act as a cost protection measure. They gather information meant to prevent a Sponsor from investing in a trial with little chance of success or that is likely to be delayed or go over budget.
Depending on the type of Feasibility study commissioned, it can be used to help determine:
Feasibility studies are critical when applying a new Investigational Medical Product (IMP) requires gathering data from several countries.
Many international studies choose to expand to prevent delays related to patient recruitment. In these cases, feasibility studies serve to collect information for future study placement assessments. Yet, it is often hard for a CRO to assess whether a site has the capabilities and infrastructure to work with a specific protocol from a distance. In addition, a remote sponsor may not be able to see the regulatory, ethical, or logistical challenges that will arise from site distribution.
A program or study-level feasibility study will evaluate a protocol – or often, a protocol idea– and determine whether it will be relevant and likely to succeed. This will involve looking at:
- The study design
- The doses and regimes used
- The required number of participants
- The scope and length of the trial
- The presence of special regulatory permits is needed before starting
Suitability of vendors and partners
At the program and the study level, the feasibility team can look at the possible partners, vendors, or CROs about to embark on a large clinical trial with a particular Sponsor.
Perhaps ironically, feasibility studies also often serve to assess whether the Feasibility CRO and the Sponsor can find common ground. As they tend to be smaller and more contained projects, they can test the waters before commissioning a clinical trial.
How to Choose the Right Feasibility CRO
Because of their predictive nature, feasibility studies require a specific skill set that many CROs do not offer.
A feasibility study will only be as good as the insight it provides. In turn, this will be determined by the following:
Experience and expertise in feasibility studies
Many clinical directors who can design a trial, or conduct a study neatly, may not necessarily have the management experience to do so “on paper”.
Experience in the subspecialty
Predictions and projections can only be made when one has a thorough knowledge of a particular speciality. Because of this, a feasibility CRO should have direct experience both in the type of studies, and the subspecialty handled.
If the CRO has conducted studies with similar models before, it will also draw from that experience to provide a more accurate assessment.
Access to good modelling techniques
Modelling exercises can help a Sponsor preempt various scenarios and determine whether they will affect a trial’s viability. This will be reflected in the study’s recommendations and can serve to mitigate much of the uncertainty.
Modelling experience is critical for any studies that focus on regulatory or logistical aspects
Strong presence in a region or country
For site-level feasibility studies, the right feasibility CRO should have access to on-site managers or those who can approach nearby medical institutions. Site visits and interviews with key local stakeholders may also be necessary.
What are the top Feasibility CROs?
At TrialTop, we have listed several CROs who provide Feasibility study services, among other clinical research services. These companies encompass Europe, the Asia Pacific region, and the United States.
Some of the top companies in this niche include:
- ACROSS Global