4 Reasons Not to Start a Phase 1 Trial Without a CRO

Posted by WCCT Global on July 14th, 2021

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.

Partner with WCCT Global for a smooth clinical trial at https://sponsor.wcct.com/

Original Source: https://bit.ly/3AWdVO9