Trying to start a Phase 1 clinical trial
without the proper resources and experience could potentially lead to
unsatisfactory results. Additionally, it could cause delays and hidden costs,
quickly outpacing the budget of the study. There are plenty of reasons your
organization might not want to start early clinical
development
without help from a contract research organization (CRO). Here are some of the
most important variables to consider.
Delays From Errors in
Paperwork or Procedures
Without proper experience in early clinical development, the beginning phases
of your study can grind to a halt. Any clinical trial requires plenty of
paperwork to fill out, procedures to determine and submissions to make. Trying
to complete these without an experienced team can lead to delays, including the
need to redo submissions or refine your procedures. Partnering with a CRO means
your trial has access to a team with experience writing these documents and
knowledge of how to create proper procedures. This can help you avoid
unforeseen delays before the clinical study has begun.
Inefficient Recruiting
Procedures
Recruiting forfirst in human
clinical trials
can be daunting, and that is where a CRO can be incredibly beneficial. Trying
to develop a recruiting policy without the experience of a CRO can lead to a
lack of participants. From the study design to the stipend offered, many
factors can impact the number of participants you attract. Plus, you should
also consider contingency plans, from participant transportation to further
recruiting if participants leave the study. Instead of being blinded by
unanticipated factors, a CRO has the necessary experience to create efficient
procedures that can make the recruiting and retention process smooth.
Misidentifying Risk
Factors
No two clinical studies are the same, but strategies for evaluating risk
factors can cross over from one study to another. With experience, it’s
possible to identify both common and uncommon risk factors, which are essential
for an effective Risk Mitigation Plan. From identifying stakeholders to
determining appropriate categories and scoring, assessing risks and adding
details, you will want to partner with an experienced CRO that can identify as
many potential risks as possible.
Lack of Resources
Finally, if you start a Phase 1 clinical trial without the help of a CRO, you
may not have access to the resources necessary for your study. If you do not
have access to proper Phase 1 clinical
trial units,
you may not be able to conduct necessary procedures safely and efficiently. You
might also lack a laboratory or a clean room dedicated to sterile drug
preparation. Partnering with a CRO means you have direct access to the
resources your clinical trial might need. If the CRO doesn’t directly offer a
resource, they will have a list of preferred providers ready to provide it.
Without the necessary resources, you cannot confidently start your study. If
you do start without some resources, you will most likely have to pause the
study later to obtain the resources, causing potentially costly delays.
About WCCT Global, an
Altasciences company
WCCT Global, an
Altasciences company, is a full-service early phase contract research
organization (CRO) that caters to the pharmaceutical, biotechnology, and
medical device industries. With WCCT, partners sponsoring a clinical trial are
offered a collaborative, innovative, and agile approach to clinical research.
Utilizing specialized regulatory and clinical professionals, WCCT creates an
unmatched research experience for partners. The CRO also offers partners access
to resources that are essential for early clinical development, such as an
80,000-square-foot clinical pharmacology unit (CPU) with 180 beds for Phase 1
clinical trials. The CPU also includes a USP-797 compliant room for sterile
drug preparation, as well as a CLIA-certified and CAP-accredited on-site Safety
Reference Laboratory. WCCT has extensive Phase 1 clinical trial experience and
offers expertise in Ethnobridging, First-in-Human, infectious disease and
vaccines, ophthalmology and women’s health clinical trials. The CRO is known as
an industry leader in Asian Ethnobridging studies, particularly with Japanese
participants.
