RegDocsThe new service aims to eliminate common errors in the registration and submitting of applications that accompany any intention to engage in animal and especially, human trials. Delays in processing may occur simply when an address is incorrect, the correct submission form is not used, a cover letter is missing or the submission is not bound.
While there are regulations specifying procedures to be used for regulatory submissions, the process is a minefield of information and measures, opening up a unique opportunity to provide a much-needed service.
easyStart is an outsourcing service designed to handle the completion and speed the submission of required regulatory documents for clinical trials, dramatically decreasing the time it takes a researcher to begin participating in a trial.
While designed for researchers, pharmaceutical companies conducting these research trials benefit from easyStart as well.
easyRegDocs said the use of easyStart when conducting clinical research results in expedited submission of all site regulatory documentation, allowing for faster startup times, extending time for patient recruitment, and reducing costly study delays or timeline extensions.
"What makes the service unique is that it adds efficiency to the entire start-up process. The research site can offload tedious, time-consuming work; and the sponsor saves significant money and time by speeding study startup and preventing expensive delays in their overall study timeline," commented easyRegDocs company co-founder Ian Brill.
easyRegDocs join a whole host of organisations who specialise in this regulatory requirement, which often forms the bulk of an application.
With clinical trials and the experimental methods under scrutiny like never before, correct documentation is crucial to successful approval.
Organisations include Albany Molecular Research, who specialise regulatory documentation such as, Chemistry, Manufacturing, and Control sections of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs), Type II Drug Master Files, European Drug Master Files (Active Substance Master Files), and New Drug Submissions (NDSs).
Likewise SRI International provides services that include pre-IND meeting with FDA, preparation and the update of Master Files, Investigator's brochure and Annual Reports
In addition the organisation provides additional submissions and amendments as necessary for successful filling and maintenance of an IND