Overview of typical review practices and how to change review into strategic activity

1. Enhancing Strategic Document Review Practices Gregory Cuppan Managing Principal McCulley/Cuppan

3. Consider the concept of strategic review

4. Consider some aspects of “best practice” to improve efficiency and outcomes2

5. Question What is your characterization of a good reviewer? What attributes/parameters makes for a good round of review? 3

6. Fact Review is a misapplied term for what occurs in the judgment/analysis of documents 4

8. Assessment

9. Critique

10. Review5

11. Most People Do Not Know How To Review We were never formally trained in the practice of review Research suggests most people learn (ad hoc manner)only how to inspect or critique a document 6

12. What is Real Value Derived from Review? Consider the following: Surveys and project analyses suggest document review practices in the majority of pharmaceutical companies are remarkably costly, inefficient, and poorly managed ETS study with 53 “distinguished reviewers” showed inter-reviewer correlation of .31 on review of 300 documents PM Rothwell & N Mayo papers both show that reviewer agreement is no greater than chance occurrence 7

14. First review on advanced drafts (85%+ of document content is in place)

15. Document analysis (inspection) is at surface level

16. Data accuracy

17. Syntactical

18. Lexical

19. Expert-focused method

20. Experts in conduct and analysis of science not necessarily experts in judging suitability of text for a target audience8

22. Analysis completed in isolation

23. Comments submitted to author/document owner

24. Author compiles and manages comments

25. Author makes changes in the document

26. For “important” documents—meeting held to demonstrate changes and adjudicate/refine review commentary

27. Process starts over again9

29. Are to act as surrogate for the final user (consumer) of a document and verify

30. Strategy effectively enacted

31. Messages addressed and defended

32. Issues resolved

33. Document is “habitable” for target audience

34. Readable

35. Usable10

36. Improving Efficiency of Review 11

38. People

39. Time 12

41. Staged review

42. Review standards

43. Review techniques13

44. For further information on Improving review practices Come Join Us at our webinar on February 24, 2010.Full details available at: www.mcculley-cuppan.com