Optimize Labor and Skills in Early Phase Clinical Trials with Intelligent Staff Resourcing

The success of a Phase 1 clinical trial can come down to how optimally you assign clinical site personnel. Without strategic planning, a study could potentially incur high costs or face other obstacles for trial sponsors. How, then, can you ensure that the staff chosen for your Phase 1 clinical trial units is being assigned correctly to keep costs down and create efficient processes? Here are some tips for evaluating the variables at your clinical trial location.

Utilize General Training

Each Phase 1 clinical trial unit will have general training and onboarding for new staff. This may consist of reviewing the employee handbook, completing coursework and certification requirements, competency testing before receiving a procedural assignment, ICH (E6) and GCP guidelines, and other types of training. However, what’s most important is that staff are trained for specific procedures in your clinical trial protocol. For optimal efficiency, staff should be familiar with protocol-specific requirements, such as a specific type of blood draw.

Determine Route of Administration

During early clinical development, a route of administration will be determined for the clinical trial. The trial drug could be administered intravenously, through a transdermal patch, inhalation, or another route. The staff assigned to the clinical trial, especially the dosing staff and study coordinator, should have experience with the specific route of administration your trial’s protocol calls for.

Is the Interval of Dosing Specified?

The dosing interval may or may not be specified in the protocol, depending on whether you are allowing for flexibility in determining the time between participant doses. The dosing interval can affect your staffing needs because participants may overlap. Can two staff members safely cover multiple procedures over the course of the day, given a specified dosing interval? Viewing procedure logs can help determine the overall number of staff needed on a given day.

Staff Procedural Times and Conflicting Schedules

Procedures take time to prepare, and dosing intervals may not account for preparation times. Staff should have time between procedures to gather necessary supplies, such as blood collection tubes or other tasks like confirming an accurate tube count per subject draw. A staff that feels rushed could lead to mistakes, negatively impacting the study.

Assigning Staff Based on Procedural Complexity

Understanding the level of certification or training needed for each procedure can affect the trial’s budget and the way the research is conducted. For example, a registered nurse is not needed for simple tasks like measuring height and weight, so these assignments can be handled by staff members with fewer certifications. It is usually best practice to reserve higher-trained staff for more complex tasks, such as dosing.

Staff Experience with Equipment or Instrumentation

If a Phase 1 site needs to bring in new equipment to perform the procedures outlined in your protocol, it can be best practice to assign a staff member with prior experience with these procedures to avoid as many risks as possible. Otherwise, an outside vendor, external location, or qualified trainer may be needed. The best Phase 1 clinical trial units will use their resources to the fullest potential to benefit the study.

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. When sponsoring a trial with WCCT, partners can take advantage of a collaborative, innovative, and agile approach to clinical research. WCCT employs specialized regulatory and clinical professionals, giving trial sponsors an unmatched research experience. The CRO offers partners access to crucial resources for early clinical development, including an 80,000-square-foot clinical pharmacology unit (CPU) with 180 beds for Phase 1 clinical trials. The CPU includes a USP-797 compliant sterile room for drug preparation, a Peripheral Blood Mononuclear Cell (PBMC) processing laboratory, and a CLIA-certified and CAP-accredited on-site Safety Reference Laboratory. With extensive Phase 1 clinical trial experience, WCCT also offers trial partners expertise in Ethnobridging, First-in-Human, infectious disease and vaccines, ophthalmology and women’s health clinical trials. Plus, the CRO is recognized as an industry leader in Asian Ethnobridging studies, specifically with Japanese participants.

Partner with WCCT and utilize their trained, experienced staff at https://sponsor.wcct.com/

Original Source: https://bit.ly/3zZhT7W


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