Procedure: Non-clinical data SEND conversion
Country: Global Procedure
Version #: 01/03/2024
Author: Vlad Reznikov
Editor: Daria Kostiuchenko                                                                         

ID: GP-PhR-SND-SR
Category: Pharmaceuticals
Validity: Until Submission
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.                                                             

SUMMARY

SEND stands for Standard for the Exchange of Nonclinical Data, and it is a set of data standards developed by the Clinical Data Interchange Standards Consortium (CDISC) for the submission of nonclinical data to regulatory authorities, including the U.S. Food and Drug Administration (FDA).  SEND is designed to standardize the format and structure of nonclinical data, making it easier for regulatory agencies to review and analyze the data submitted by sponsors during the drug development process. SEND is structured around defined domains that correspond to specific types of nonclinical data, such as general observations, pharmacokinetics, and toxicology. Each domain has standardized variables and terminology, making it easier for regulatory agencies to interpret and evaluate the data.
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Must-Have Requirements, Recognized Standards, and Certifications:                                                             

  • In-Life Source in Provantis or PDF format    
  • Pathology  in Provantis or PDF format                                     
  • Bio-Analytics/Toxicokinetics in Excel/xpt format
  • Final Study Report in PDF format                                                

Nice-to-have:

  • Provantis format

Typical Gaps and Deficiencies: Incorrect formatting                                                            

Implementation Period: Immediately                                                              

Deliverables: SEND Package (xpts, nSDRG, xml, pdf)                                                                  

Consistency: Consolidated Quantitative and Qualitative Comparison Report on 100% Reconciliation against Study Report                                             

Conformance: eDataValidator against all applicable rules. Optional cross-compare with Pinnacle 21 validator.  DSOAR Report, if needed, to correct source data or Study Report.  90-day warranty remedies for reported issues

PHASE

TASK

TASK

START

DURATION

 

Fee

 

KPI

NUMBER

TITLE

OWNER

W/M/Q/Y

in weeks

3rd Party 

Service 

State

 

0

In-house Pre-Submission Activity

       

  0.1

NDA signing or validation

Executor

week 1

1

    

  0.2

Contract Closing

MAH

week 1

1

    

  0.3

POA issuance and shipping

MAH

week 1

1

    

  0.4

Invoice is sent to MAH and paid

Executor

week 1

1

    

  0.5

Document processing

Executor

week 2

1

    

  0.6

SOW is approved by MAH

Executor

week 3

1

   

SOW

I

SEND conversion

       

  I.1

Documents and data assembling, forwarding to Executor

MAH

week 4

1

    

  I.2

Data conversion and validation

Executor

week 5

4

   

SEND Package

  I.3

Pre-submission approval

MAH

week 9

1

    

  I.4

On-line submission to NRA (e.g. FDA)

Executor

week 10

1

   

Submission

  I.5

Follow-up and concluding with MAH

Executor

week 11

1

    

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate Signing

MAH

week 12

1

    

  F.2

Final Invoice

Executor

week 12

1

    

  F.3

Final Payment

MAH

week 13

1

    

  F.4

Contract Termination

Executor

week 14

1

    

  F.5

Archiving and limiting access

Executor

week 15

1

   

Archiving

                                     

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