WE CREATE SPECIFIC SOURCE DOCUMENTS DESIGNED TO MEET ALL PROTOCOL NEEDS
WHO WE ARE
Vastness is a team of experienced study coordinators that have been involved in clinical research for over 15 years. We are immersed in research data all day, and we understand the importance of reliable source documents for a successful clinical trial. Our goal is to reduce the obstacles of clinical research and improve your efficiency.
We rely in our experience to create customized source documents that are intuitive and which account for all protocol specifications. We follow protocol requirement, eCRF guidelines, annotated case report form and Good clinical practice to create our source documents. Our source documents also take into account the layout for the EDC system which study coordinators and monitors will have to work with throughout the study, and accommodates for all the requisite values that need to be input into the EDC system. This makes it easy for coordinators to collect the data and transcribe it to EDC as well as allowing monitors to review the data more efficiently.
ABOUT OUR SOURCE DOCUMENTS
One of the most common findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits and FDA inspections. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data.
Therefor our mission is to minimize the most common findings and provide source documents that would help the pharmaceuticals conduct a successful clinical trial.
“OUR SOURCE DOCUMENTS SUPPORT ALL
PHASES AND TYPES OF THERAPEUTIC INDICATIONS.”
“PROPER SOURCE DOCUMENTATION IS THE BEGINNING OF A CLEAN, VERIFIABLE AUDIT TRAIL.”
Apply the ALCOA standard to achieve data quality:
ATTRIBUTABLE
LEGIBLE
CONTEMPORANEOUS
ORIGINAL
ACCURATE
WHAT CLIENT SAY
Megan Askew, CRA
ICON
It’s very rare in this industry to find great source documents that capture every detail of the protocol, but working with these source documents I have found that they have truly captured everything needed to make a study successful. This not only saves time but ensures the accuracy and integrity.