PIL Readability Testing
Quality and acceptance of the PIL readability testing
is our number one priority. This sets us apart from other providers
with an approval guarantee.
PIL Readiabilty Testing Quality Overview:
- The testing is managed by a regulatory affairs associate to
ensure the methodology is adhered to.
- The interviewers receive training and are medically trained and
licensed to administer medicines.
- Interviewers are open to client audits or “sit ins”.
- The participants’ demographic data and contact details
are retained to be able to review and validate the quality of participants.
- The participants all sign a non disclosure and data release form
for health agencies.
- Every interview is recorded and delivered to the client for their
- Every interview and answer sheet is reviewed and signed for by
the interviewer and project manager.
- Transfer of data is performed in accordance with SOP.
- The reports are created using quality templates.
- The reports are delivered first to the clients in draft format
for review. Revisions are made based on the client’s discretion.
- Final reports are delivered in PDF with 2 signatures of Pharma-EU
- Final reports are delivered in electronic format ready for submission,
a hard copy of the report and CD is also sent which includes the
participant’s applications complete with demographic data
and contact information, non disclosure and data release forms,
a CD of the voice recordings and the interviewer’s notes
and answer sheets.
Testing Providers for: