It can be exciting when your biotech start-up decides it is time to move to first in human clinical trials.
However, that excitement can quickly sour when delays occur or the
budget proves to be insufficient. By partnering with a contract research
organization (CRO) with experience, your company can avoid delays and
cost issues, streamlining trials and successfully moving on to the next
phase of product development. Here are some of the ways in which a CRO
can help avoid common mistakes and missteps an inexperienced company may
make.
Using Experience to Develop a Budget
If your company does not have experience in early clinical development,
it may be easy to misjudge the budget. Resources, supplies, equipment,
marketing, and staffing and nursing fees all affect the budget. The
Schedule of Events, or SOE, is ultimately what a budget should be
derived from. Without a proper SOE, the budget could be off, not
accounting for various fixed or flexible costs associated with
assumptions made about the schedule. A CRO likely has experience running
clinical trials and understands what assumptions should be made and
which costs are flexible instead of fixed.
Managing Prep Work
The
prep work is not just developing a budget, however. The budget should
be developed in tandem with other aspects of prep work, such as project
proposals. This includes timelines, clinical conduct plans, and
recruitment strategies. You need to make sure your budget and timeline
accounts for recruiting activities that occur once the study begins,
such as writing participant-facing materials, and advertising for
participants.
Protocol Designing and Evaluation
A
proper and detailed evaluation of the protocol is vital to a successful
clinical trial. Defining the inclusion and exclusion criteria for study
participation through factors such as age, gender, and ethnicity is a
first step. Other tasks include creating a study design that meets the
study objectives and is also attractive for volunteers to participate.
Determining whether the participants should be confined to a facility or
not, and what kind of procedures and recourses are needed must be
carefully reviewed before recruitment begins. Without experience, it can
be easy to make a mistake, creating delays in the trial. This also
costs resources such as time and money, which your company may not have.
CROs either have access to the proper resources or a list of
supplemental vendors they can subcontract.
Utilizing Proper Resources
Does
your company have access to the necessary resources needed to conduct
clinical research? For example, your company may need Phase 1 clinical trial units
in which to conduct the study. This can also include overnight units,
labs, sterile rooms for drug preparation, and more. Securing proper
resources is one of the keys to successfully conduct a clinical trial.
Employing Trained Staff to Perform Research
A
CRO can handle medical writing, regulatory support, project management,
data management, clinical monitoring and biostatistics, and more.
Without prior experience with these, they can be very difficult, again
leading to delays. Partnering with a CRO and letting trained staff
handle tasks your staff may not have experience with can lead to a
successful, streamlined clinical trial.
About WCCT Global, an Altasciences company
WCCT
Global, an Altasciences company, is a full-service early phase contract
research organization (CRO) for the pharmaceutical, biotechnology and
medical device industries. WCCT offers partners a collaborative,
innovative, and agile approach to product development, utilizing
specialized regulatory and clinical professionals. The CRO can provide
the necessary resources for early clinical development, including a
80,000-square-foot clinical pharmacology unit (CPU) with 180 beds. The
CPU is ideal for conducting Phase 1 clinical trials, particularly for
studies with an overnight component. This includes a CLIA-certified and
CAP-accredited on-site Safety Reference Laboratory as well as a USP-797
compliant room for sterile drug preparation. WCCT has extensive Phase 1
clinical trial experience, with expertise in Ethnobridging,
First-in-Human, infectious disease and vaccines, ophthalmology, women’s
health, and nicotine and tobacco clinical trials. WCCT is recognized as
an industry leader in Asian Ethnic Bridging studies, particularly with
Japanese participants.
Partner with WCCT and utilize the CRO’s experience with Phase 1 clinical trials at https://sponsor.wcct.com/
Original Source: https://bit.ly/39PBNqN
