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Developing a Workflow Application: Clinical Data Management

Extracts from this document...

Introduction

The ABC Pharmaceutical Company is a leader in the discovery, development, manufacturing, and marketing of prescription medicine. There goal is to provide a broad range of innovative, effective and safe products. There products are provided to patients through healthcare professionals around the world.

In 2004, the Company posted sales of USD 18.5 billion. Research & Development spending increased substantially and reached 18.8% of sales. The Development portfolio involves more than 100 projects - including potential new products in various stages of clinical development. 

Clinical trials are research studies which try to answer scientific questions and find better ways to treat or prevent diseases.  A clinical trial is conducted to determine whether a new drug or treatment is both safe and effective in people. Extensive clinical trails need to be conducted before being approved by the Food and Drug Administration (FDA) for sale in the United States.

Almost 50% of medical needs are still to be answered by pharmaceutical and biotechnology companies. As specialists with all the skills in bringing chemical entities to the patient, pharmaceutical companies spend half of overall drug development costs in phase II, III and IV. New drug discovery technologies and methods increasingly fill the pipeline of products going into phase I.  


In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000)

...read more.

Middle

min

10.0

7.2

2.5

Time to complete visit

min

39.6

Data Entry and Review Personnel

Cost/DE/DR Person

$/person

$48

Hours/week

hours/week

25

Data Entry/Review staff as percentage of whole DP group

% (of cost? Of employees?)

75%

Data Entry Productivity

Improvements

Data Entry and Review

Access to Module per visit

min

0.1

Data entry/Review composed of

min

Navigation

min

0.25

Soft edits

min

0.25

Data manipulation/storage

min

0.25

Accelerators

min

0.25

Verification

Assume no improvements

min

0

Total savings per module

min

1.1

Total savings per visit

min

11

Productivity Improvement

Improvement in data entry/review

%

28%

Overall improvement in DE/DR as a whole

%

21%

Savings Summary

Visits entered/reviewed per year

min

400,000

Time saved/year

min

4,400,000

Time saved/year

hr

73,333.33

Cost savings/year

$

$3,520,000.00

Assumptions:  For the business-case, a default study with:

  • 10 modules per visit
  • 10 visits per patient
  • 500 patients per trial

Has been used as the benchmark for quantifying gains based on the technology improvements made to facilitate expedited data entry.

The overall success criteria will be demonstrated with increased productivity – more visits per person overall for trial OR realized by a savings in time which could result in fewer persons to complete units of work.  Both point to a reduction in cost to conduct the defined trial due to fewer resources used, or in reduced cycle time with same resources used, or in the ability to add on additional studies without adding extra resource.

Main Objectives

The objective of the newly designed sub processes addresses the determined inefficiencies of how the tasks of the data entry and review sub processes were being completed.  Each as-is sub process was reviewed and hand-offs were identified between each sub process. The redesign effort has instituted new milestones and those milestones are to be integrated into the workflow management system.  Technology enablers have also been reviewed at this juncture and a series of requirements have been drafted to help support the new process changes.

...read more.

Conclusion

COUNTRY

An international location that conducts clinical studies for specified protocol

Data Entry / Data Modification Personnel:

These are the individuals responsible for entering or modifying data in the database for a particular trial.  They would require “read/write/delete” access to the data.  

Data Review Personnel:

These are the individuals responsible for reviewing the data in the database for a particular trial.  They would require “read/write/delete” access to the data.

Access Rights:

  • Read access will allow viewing of the data by any personnel part of the overall CDM process and system support staff required to trouble shoot issues with the system.
  • Read/Write access will allow viewing and manipulation of the data by the data entry or review user of the system .
  • Support will allow running required scripts against the data for validation.
  • Read/Write/Delete will allow viewing, manipulation and deletion of the data by the data entry or review user of the system.

Roles

Access Code

Access Type

Access Level

CDE_USER

CDER

IN_HOUSE (Data Entry Staff)

READ

CDE_USER

CDE_MANAGER

CDEW

IN_HOUSE (Data Entry Staff)

READ/WRITE

CDE_SUPPORT_USER

CDES

SUPPORT STAFF

SUPPORT

CDE_SUPPORT_USER

CDE_SUPPORT_MANAGER

CDET

SUPPORT MANAGER

SUPPORT

CDE_USER

CDE_MANAGER

CDE_DELETE_MANAGER

CDED

IN-HOUSE DELETE VISIT

READ/WRITE/DELETE

DR_USER

DRR

IN_HOUSE (Data Entry Staff)

READ

DR_USER

DR_MANAGER

DRW

IN_HOUSE (Data Entry Staff)

READ/WRITE

DR_SUPPORT_USER

DRS

SUPPORT STAFF

SUPPORT

DR_SUPPORT_USER

DR_SUPPORT_MANAGER

DRT

SUPPORT MANAGER

SUPPORT

DR_USER

DR_MANAGER

DR_DELETE_MANAGER

DRD

IN-HOUSE DELETE VISIT

READ/WRITE/DELETE

Summary

Drug development demands for a short time to market, as well as specific regulations make medical device studies a tough challenge. An average 80 clinical trials involving 5000+ patients are necessary for a new drug application. Shortening development time allows more drugs to enter the marketplace, offering a return on investment to shareholders.

This new system achieves the following goals:

  • Reduces wait times (In-House Data Entry Staff)
  • Eliminates Wait time before events
  • Reduces the number of processes
  • Transforms the process to events
  • Minimizes number of contact points
  • Make processes/Events parallel
  • Improve quality at each step
  • Improve cycle time
  • Execute the process with minimum use of resources

image08.png

Maryian Michail        Page         5/4/2007

...read more.

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