Each year, regulatory non-compliance costs the life sciences industry billions
of dollars in fines, recalls, audits and more. To avoid these missteps,
companies rely heavily on experienced compliance teams, which provide
oversight from the earliest R&D to the very end of the product lifecycle.
Compliance teams do critically important work across a wide range of
functions, but they face a raft of challenges. Simply keeping pace with the
dizzying, ever-growing array of national and international standards is
difficult enough, but groups also face obstacles in securing needed resources,
building internal buy-in, strengthening training programs and more.
This report provides detailed benchmark data and case studies for teams
seeking to improve their organizations' approaches to compliance. With metrics
on budgets, staffing and support, as well as specific challenges, the findings
provide a guide for compliance teams across all company types and sizes.
Strengthen the Role of Compliance within Your Organization
Team structure is critical to success. Use the report's team profiles to build
effective, empowered compliance groups. Understand internal alignment models,
leadership, staffing levels and outsourcing.
Create, Train, and Monitor Compliance Effectively
Striking the balance between over- and under-compliance is an art and a
science. Leverage digital training to keep employees up-to-date with the
latest policies and regulations, enforce employee accountability and escalate
problems via proper channels. Explore training metrics to spot recurring
trouble spots, improve processes and avoid costly compliance issues.
Manage a Growing List of Global Standards and Regulations
Compliance teams juggle a staggering number of laws, regulations and
guidelines in markets around the globe, which means increased - and
increasingly complicated - workloads. Implement best practices and successful
processes to meet the internal and external challenges of this reality head on.
Table of Contents
Table of Contents
9 Executive Summary
11 Study Methodology
12 Study Definitions
13 Profiled Companies and Therapeutic Areas
13 Three Key Recommendations
19 Structure and Challenges; Budgets and Staffing of Compliance
Teams
20 Structure: Align Compliance with Internal Expertise
38 Time and Budget Largely Spent on Audits, Training and Documentation
48 Compliance Training Processes and Metrics
58 Compliance Team Budgets and Staffing
67 Compliance Challenges: Internal versus External
75 Compliance Team Profiles
76 Company I Compliance Team Profile
82 Company J Compliance Team Profile
87 Company O Compliance Team Profile
92 Company F Compliance Team Profile
97 Company C Profile
103 Company R Profile
108 Company K Profile
113 Company M Profile
KEY METRICS
Chapter 1: Structure, Activities, Budgets & Staffing, and Challenges
Chapter Benefits
Centralize compliance oversight behind at least one high-level individual,
such as a chief compliance officer.
Empower specialists to do ground-level compliance work within different
departments.
Benchmark budget and time spent across key compliance activities.
Find the right balance between over- and under-compliance.
Examine staffing over a 6-year span with year-over-year metrics and
projections for the future.
Implement processes to stay on top of changing regulations across the
globe.
Manage critical internal and external challenges for all compliance groups.
Leverage digital training to increase employee understanding and minimize
issues.
Explore a case study of one company using compliance as a strategic means
to ease entry into emerging markets.
Key Metrics
41 charts focused on structure, resources, training and more:
Structure and Responsibilities
Structure of compliance function for all companies (broken down by company
type: Top 20, Top 50, medical device and small/biotech)
Percentage of budget and time spent on specific compliance activities (by
company type)
Frequency of contact with regulatory agencies
Functions within compliance teams' jurisdiction (by company type)
Leadership of compliance teams
Average age of compliance teams (by company type)
Training
Percentage of compliance teams that conduct internal training, new hire
training, and external personnel training
Frequency of internal compliance training
Reasons for ad hoc internal compliance training
Units (hours, days, etc) used to measure compliance training (by company
type)
Budgets
Compliance budgets for 2010-2012 (by company type)
Sources of compliance budgets
Staffing and Outsourcing
In-house and outsourced compliance FTEs
Staffing trends from 2010-2012
Three-year projections of staffing trends for 2013-2015
Average in-house and outsourced FTEs per compliance team (by company type)
Challenges and Performance
Ratings of external compliance challenges
Ratings of internal compliance challenges (by company type)
Ratings of internal departmental compliance
Chapter 2: Compliance Team Profiles
Chapter Benefits
Find tailored benchmarks with 8 in-depth case studies across different
company sizes:
6 pharma teams (two Top 20, one Top 50, three small/biotech)
2 device teams
Draw connections between individual teams' structures, resources, staffing
and challenges.
Delve into spending-per-activity and time-per-activity data to streamline
workflow and compare team performance.
Understand different companies' approaches to compliance structure.
Identify different compliance teams' most pressing challenges.
Key Metrics
32 charts across 8 separate company profiles:
Team structure, leadership and internal reporting line
Team budget and staffing data
Percentage change in team headcount and budget, 2010-2012
Percentage of time and budget allocated to specific compliance activities
Ratings of internal and external challenges facing team
CHARTS AND GRAPHICS
Executive Summary
Three Key Recommendations
15 Figure E.1: All Companies: Internal Compliance Units
Structure and Challenges; Budgets and Staffing of Compliance Teams
Structure: Align Compliance with Internal Expertise
21 Figure 1.1: Structure of Compliance Function: All Companies
22 Figure 1.2: Structure of Compliance Function: Top 20 Companies
23 Figure 1.3: Structure of Compliance Function: Top 50 Companies
24 Figure 1.4: Structure of Compliance Function: Small/Biotech Companies
24 Figure 1.5: Structure of Compliance Function: Device Companies
28 Figure 1.6: Frequency of Contact with Regulatory Agencies
30 Figure 1.7: Compliance Team Oversight: All Companies
31 Figure 1.8: Compliance Team Oversight: Top 20 Companies
32 Figure 1.9: Compliance Team Oversight: Top 50 Companies
33 Figure 1.10: Compliance Team Oversight: Small/Biotech Companies
34 Figure 1.11: Compliance Team Oversight: Device Companies
35 Figure 1.12: Level of Executive Leading Compliance: All Companies
36 Figure 1.13: Level of Executive Leading Compliance, by Structure
37 Figure 1.14: Average Age of Compliance Teams, by Company Type
Time and Budget Largely Spent on Audits, Training and Documentation
42 Figure 1.15: Percentage of Budget and Time Spent, by Compliance
Activity: All Companies
44 Figure 1.16: Percentage of Budget and Time Spent by Compliance
Activity: Top 20 Companies
45 Figure 1.17: Percentage of Budget and Time Spent, by Compliance
Activity: Top 50 Companies
46 Figure 1.18: Percentage of Budget and Time Spent, by Compliance
Activity: Small/Biotech Companies
47 Figure 1.19: Percentage of Budget and Time Spent, by Compliance
Activity: Device Companies
Compliance Training Processes and Metrics
49 Figure 1.20: Percentage of Compliance Teams that Conduct Internal
Training
50 Figure 1.21: Frequency of Internal Compliance Training
51 Figure 1.22: Reasons for Ad Hoc Internal Compliance Training
52 Figure 1.23: Internal Compliance Training Units: All Companies
54 Figure 1.24: Internal Compliance Training Metrics:Top 20 and50 Companies
55 Figure 1.25: Internal Compliance Training Metrics: Small/Biotech and
Device Companies
56 Figure 1.26: Percentage of Compliance Teams that Conduct New Hire
Training
57 Figure 1.27: Percentage of Compliance Teams that Conduct External
Personnel Training
Compliance Team Budgets and Staffing
59 Figure 1.28: Compliance Budgets for 2010 - 2012, by Company Type
60 Figure 1.29 Compliance Budget Source: All Companies
62 Figure 1.30: Average In-House and Outsourced FTEs per Compliance Team,
by Company Type
63 Figure 1.31: In-House and Outsourced Compliance FTEs for Companies that
Outsource
64 Figure 1.32: Average Percentage of Outsourced Compliance FTEs: All
Companies that Outsource
65 Figure 1.33: Staffing Trends from 2010 - 2012: All Companies
66 Figure 1.34: Three-year Predictions of Staffing Trends: All Companies
67 Figure 1.35: Ratings of External Compliance Challenges: All Companies
Compliance Challenges: Internal versus External
69 Figure 1.36: Ratings of Internal Challenges: All Companies
70 Figure 1.37: Ratings of Internal Challenges: Top 20 Companies
71 Figure 1.38: Ratings of Internal Challenges: Top 50 Companies
71 Figure 1.39: Ratings of Internal Challenges: Small/Biotech Companies
72 Figure 1.40: Ratings of Internal Challenges: Device Companies
73 Figure 1.41: Ratings of Departmental Compliance: All Companies
Compliance Team Profiles
Company I Compliance Team Profile
78 Figure 2.1: Background and Structure: Company I
79 Figure 2.2: Compliance Team Resources: Company I
80 Figure 2.3: Compliance Team Activities: Company I
81 Figure 2.4: Ratings of Challenges: Company I
Company J Compliance Team Profile
83 Figure 2.5: Background and Structure for Company J
84 Figure 2.6: Compliance Team Resources: Company J
85 Figure 2.7: Compliance Team Activities: Company J
86 Figure 2.8: Ratings of Challenges: Company J
Company O Compliance Team Profile
88 Figure 2.9: Background and Structure for Company O
89 Figure 2.10: Compliance Team Resources: Company O
90 Figure 2.11: Compliance Team Activities: Company O
91 Figure 2.12: Ratings of Challenges: Company O
Company F Compliance Team Profile
93 Figure 2.13: Background and Structure: Company F
94 Figure 2.14: Compliance Team Resources: Company F
95 Figure 2.15: Compliance Team Activities: Company F
96 Figure 2.16: Ratings of Challenges: Company F
Company C Profile
99 Figure 2.17: Background and Structure: Company C
100 Figure 2.18: Compliance Team Resources: Company C
101 Figure 2.19: Compliance Team Activities: Company C
102 Figure 2.20: Ratings of Challenges: Company C
Company R Profile
104 Figure 2.21: Background and Structure: Company R
105 Figure 2.22: Compliance Team Resources: Company R
106 Figure 2.23: Compliance Team Activities: Company R
107 Figure 2.24: Ratings of Challenges: Company R
Company K Profile
109 Figure 2.25: Background and Structure: Company K
110 Figure 2.26: Compliance Team Resources: Company K
111 Figure 2.27: Compliance Team Activities: Company K
112 Figure 2.28: Ratings of Challenges: Company K
Company M Profile
114 Figure 2.29: Background and Structure: Company M
115 Figure 2.30: Compliance Team Resources: Company M
116 Figure 2.31: Compliance Team Activities: Company M
117 Figure 2.32: Ratings of Challenges: Company M
Pharmaceutical Compliance Best Practices: Ensuring Quality Through Documentation, Training, and Auditing published by Cutting Edge Information in May 25, 2012. This report consists of 119 Pages and the price starts from US $ 7695.
