Study Startup Optimization

Study Startup
Study Startup

One of the most significant challenges associated with clinical trials is getting them started. The preparation involved to start a new clinical trial requires an incredible investment of time and resources.

Oftentimes, those who are involved in the planning process are pulled in a dozen different directions simultaneously as there are a wide array of tasks that must be completed before the trial can begin. A few such tasks include collecting regulatory documents, executing investigator CTAs, and scheduling initiation visits. 

Unfortunately, a failure to properly manage all of these responsibilities can result in trials faced with costly and frustrating startup delays.

In order to help sponsors overcome these potential barriers, Vial has developed a centralized study startup optimization process that can expedite trial initiation. Our experts understand that faster study execution can help a sponsor achieve key milestones while also allowing them to reduce costs by decreasing the startup timeline. That is why our goal is to have all Vial study sites activated within 30 days of feasibility.

At the heart of Vial’s approach is our unparalleled site network. We are able to leverage the Vial clinical research coordinators (CRCs) to complete key site start up tasks quickly and efficiently.

Specifically, our study startup optimization process relies on three key factors, which are as follows:

1. Vial CRCs and CRMs

Vial has implemented a streamlined process to ensure that all study sites can be activated simultaneously.

Our centralized regulatory team coordinates and tracks all sites’ IRB submissions. The team ensures all site documents are completed accurately and timely. The IRB will have one point of contact for our sites to streamline questions or clarifications. Our centralized regulatory team ensures all Vial sites receive IRB review and approval at one time.

Our investigator agreement team drafts the budgets and negotiates the CTA on behalf of all Vial sites. Therefore, our sponsors receive one study budget for all of Vial sites. This process reduces invoicing and payment burden as well as helps increase timely financial tracking throughout the project.

2. Standardized Systems Across All Vial Sites

One of the most significant advantages of using Vial’s startup optimization services is that every member of our site network utilizes centralized standard operating procedures (SOPs). In addition, these sites are trained on and use the same clinical trial management system (CTMS) for document storage and management. Reliance on standardized processes and technologies increases the accuracy and quality of data across our sites. 

As an added layer of data integrity protection, Vial’s quality control (QC) managers conduct routine site audits. During these audits, we review site processes and documentation to ensure site staff are adhering to established SOPs. Our robust quality control process sets the Vial site network apart from the pack. 

3. Continuous Oversight and Support from Vial CRMs

The final aspect of our study startup optimization process is continuous oversight and support for the Vial CRCs and staff members.

Our regional clinical research managers (CRMs) are typically assigned to oversee 5-6 sites within their geographic region. The CRM provides support to the site staff, ensuring timelines are met and data and documents are entered into the systems in a timely manner. The CRM evaluates the performance of the CRCs by monitoring several relevant metrics and, if needed, will allocate additional resources to ensure tasks do not fall behind. 

Cumulatively, Vial’s three-pillared study start up optimization process can reduce timelines and ensure data quality to help meet a successful study execution. 

Learn more about Vial’s Dermatology CRO

About Vial:

Vial’s mission is to run clinical trials with faster execution and higher quality in order to bring new therapies to market. Vial has over 70 employees and is based in San Francisco, California. Vial partners with Dermatologists to support their research teams and has created a network of over 35 Dermatology clinics. The Vial network has contributed to over 150 trials for many of the leading sponsors in Dermatology having run trials across common Medical Dermatology indications (Atopic Dermatitis, Psoriasis, Vitiligo, Alopecia Areata, Rosacea, Hidradenitis Suppurativa, Prurigo Nodularis among others) as well as Aesthetic Dermatology indications. The clinic network runs trials from Phase I through Phase IV.