Correcting SEND datasets for regulatory assurance
SEND ASSURE and Corrections gives you 100% assurance that your datasets will be accepted by regulatory authorities or used seamlessly in repositories. We correct against the latest SEND standards, including Controlled Terminology and Implementation Guides, so there is no uncertainty about third-party corrections.
The SEND ASSURE and Correction service benefits
When PointCross performs SEND ASSURE, we address every required change to the datasets directly, avoiding the logistical challenges of returning to the CRO. It is a cost and time saving path to quick, reliable finalization of your SEND datasets.
No CRO round-trip for corrections
We make the required changes to the datasets in place. That removes the logistical back-and-forth of returning to the CRO, so finalization is faster and stays under one accountable owner.
A cost and time saving path to finalization
For sponsors seeking quick and reliable finalization, correcting at the source is a lighter, lower-cost route than re-contracting and re-queuing the work elsewhere.
Studies outside the original scope, no new contracts
Studies that fall outside the original scope of work with the CRO can still be completed without requiring new contracts, giving you added flexibility and convenience.
Updated to the latest SEND standards
Corrected datasets are brought up to the current SEND standards, so compliance and accuracy are built in, not assumed.
From flagged dataset to submission-ready
A direct, accountable correction path that eliminates uncertainty about third-party fixes.
Assess
We review your prepared SEND datasets and identify every change required for acceptance or repository use.
Correct
We make the corrections directly against the latest Controlled Terminology and Implementation Guides, no CRO round-trip.
Assure
Corrected datasets are validated so you have full assurance they will be accepted or used seamlessly downstream.
Deliver
You receive finalized datasets, with an optional Digital Study Report for familiar review.
Digital Study Report (DSR)
For those seeking additional value, PointCross offers an optional Digital Study Report. The DSR presents the study in its original format and terminology, giving Study Directors and Sponsor Toxicologists the familiarity they expect when reviewing corrected datasets.
SEND ASSURE and Corrections, answered
What does SEND ASSURE and Corrections deliver?+
Do you have to send datasets back to the CRO for changes?+
Which SEND standards are the corrected datasets updated to?+
Can you correct studies outside the original CRO scope of work?+
What is the optional Digital Study Report?+
Finalize your SEND datasets with full assurance
Get corrected, standards-current datasets ready for submission or repository use, without the CRO round-trip. Request a no-obligation quote to get started.
