ASK THESE SEND QUESTIONS FIRST
How long does it take to receive SEND datasets?
By working with Altasciences, your SEND package will be delivered within 3 weeks of your final report. Submission ready datasets include XPT domains, Study Data Reviewer’s Guide (nSDRG), and Define.xml files compliant with CDISC specifications. This guaranteed turnaround time allows you to plan your nonclinical timeline efficiently so that you can meet your milestones.
What if I need interim SEND datasets?
Once your audit draft is finalized, interim datasets can be delivered by Altasciences within 3 weeks. If you are submitting to the FDA with a Draft report and your study falls within SEND requirements, SEND datasets are required with this submission.
When are SEND datasets prepared?
To ensure efficient and accurate delivery of datasets, SEND packages are prepared after the report is finalized. With streamlined processes and an experienced SEND team available to support your data preparation, your timelines will never be compromised.
If I’m working with a third party lab that cannot provide SEND ready files, can the files be converted by another CRO?
If you are working with a third party vendor for TK analysis that cannot provide SEND-ready files, Altasciences can convert digital files to the appropriate format. For vendors that have SEND-ready capabilities, Altasciences can incorporate these files into the larger dataset.
What processes are in place to ensure quality and regulatory adherence?
Before generating SEND datasets, an Altasciences’ Study Director and the Safety Assessment Department conduct a Quality Control (QC) review. Additionally, all data is audited by Quality Assurance (QA) prior to being exported. Altasciences’ process ensures all SEND data is reviewed by multiple parties and does not have to be modified following a QC or QA finding. Our validated submitTM system ensures data integrity as data moves from an Electronic Data Capture System (EDCS) into the SEND format. Following reviews, datasets are compared against the final report, and any differences are noted in the nSDRG.
Will I have a designated point of contact for my SEND questions?
At Altasciences, our personable and accessible SEND team is ready and able to answer your questions. At study initiation, your SEND point person will be assigned and available to assist you throughout your SEND process.
Partnering with Altasciences
As an active member of the CDISC SEND Consortium and Pharmaceutial User Software Exchange (PhUSE ) nonclinical working groups, our team contributes to the development of SEND standards and remains at the forefront of these evolving requirements.