Some of the
most critical aspects of clinical research are the early clinical
development phases. These critical stages of development not only represent a
significant commitment of time and resources for your company, but they can also
set the tone and pace for the rest of your product development. One of the
easiest ways to help ensure your product’s early clinical development goes
smoothly is to partner with a contract research organization (CRO) with
experience in Phase 1 clinical trials. This can help you optimize early
development phases and avoid delays and cost issues while helping product
development succeed.
The first thing an experienced CRO can do is help with prep work. Whether it’s
regulatory support, offering staff that can handle protocol development and
medical writing, or taking the reins of project management, a CRO can help make
preparations go much faster. From clinical monitoring and biostatistics to
medical monitoring capabilities, with proper prep work, a CRO can help achieve
the study objectives successfully while ensuring safety of study participants.
Experienced CROs can also support building proper recruitment strategies to ensure
timely enrollment and volunteer retention in first-in-human trials. Inclusion
and exclusion criteria, such as gender, age, and medical history, must be
determined to properly meet the study’s objectives. However, that is only the
first step, as participant wait-listing and screening must be performed.
Potential participants also need to be well-informed about expectations and
stipends, as well as understand procedural requirements. There are many aspects
to recruiting participants that experienced CROs can handle that may not be
obvious to companies new to clinical development.
If you are thinking of launching your product in other countries, you may want
to consider performing Ethnobridging clinical trials.
This can help reduce the cost and time of clinical development, as the process
recruits ethnic populations without leaving the country. An experienced CRO
might have a list of participants available, such as participants with Chinese,
Japanese, or Korean ethnicity.
Your company may not have access to the proper resources, such as Phase 1 clinical
trial units. These units are where the trial is conducted and can include housing
facilities for overnight trials, clean rooms for sterile drug preparation,
labs, equipment, and more. They are essential for conducting a Phase 1 clinical
trial. If a CRO does not have the proper resources, they likely have an
approved vendor list for subcontracting. In short, a CRO will have or have
access to the staff, equipment, and resources needed to properly carry out a
Phase 1 clinical trial to increase the chances of success.
