What regulatory executives think about outsourcing · 85 WHERE COMPANIES DO BUSINESS % 33% 48% 22%...
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85 WHERE COMPANIES DO BUSINESS % 33 % 48 % 22 % 31 % Primary rationale for outsourcing REGULATORY AFFAIRS WORK 33 % To temporarily manage overflow 26 % To increase capacity 19 % Other responses 17 % To enable in-house staff to focus on strategic work 5 % To save cost outsource less than 10 % of their budget 50 % outsource more than 25 % of their budget 32 % Estimated percentage of total REGULATORY AFFAIRS BUDGET that is outsourced: MOST IMPORTANT FACTORS WHEN SELECTING AN OUTSOURCING PROVIDER EXPERIENCE COST THERAPEUTIC KNOWLEDGE FIT Internet search 8 % Leveraging our in-house procurement team 10 % Working with a large CRO 13 % Using referrals from trusted sources 69 % FUNCTIONS HANDLED BY THE REGULATORY DEPARTMENT AT YOUR COMPANY? Label review of regulatory signoff Advertising regulatory signoff Regulatory CMC Pharmacovigilance Quality assurance Study startup Environmental considerations Market access or reimbursement FOR OUTSOURCING OVER THE NEXT 12 MONTHS TOP AREAS Regulatory strategy Pharmacovigilance Regulatory operations (publishing) Overflow submissions Regulatory writing Mature marketed products support Regulatory CMC Quality assurance Labeling In the first quarter of 2013, Optum Life Sciences surveyed 46 small, mid-size and large life science companies to gauge their regulatory outsourcing practices and plans. Companies represented a range of therapeutic areas — predominantly oncology, CNS, GI, CV and respiratory. Below is a closer look at their regulatory outsourcing activities. OUTSOURCING PROVIDERS ARE FOUND What regulatory executives think about outsourcing HOW outsource 11-25 % of their budget 18 % Optum Life Sciences
Transcript of What regulatory executives think about outsourcing · 85 WHERE COMPANIES DO BUSINESS % 33% 48% 22%...
85WHERECOMPANIES DO
BUSINESS %
33%
48%
22%31%
Primary rationale for outsourcingREGULATORY AFFAIRS WORK
33%To temporarily
manage overflow
26%To increase
capacity
19%Other
responses
17%To enable in-house staff
to focus on strategic work
5%To save cost
outsource less than10% of their budget50%
outsource more than25% of their budget32%
Estimated percentageof totalREGULATORY AFFAIRS BUDGETthat is outsourced:
MOST IMPORTANT FACTORS WHEN SELECT ING AN
OUTSOURCING PROVIDEREXPERIENCE
COSTTHERAPEUTIC KNOWLEDGE
FIT
Internet search
8%
Leveraging our in-house procurement team
10%
Working with a large CRO
13%
Using referrals from trusted sources
69%
FUNCTIONS HANDLED BY THEREGUL ATORY DEPARTMENT AT YOUR COMPANY?
Label review of regulatory signoff
Advertising regulatory signoff
Regulatory CMC
Pharmacovigilance
Quality assurance
Study startup
Environmental considerations
Market access or reimbursement
FOR OUTSOURCING OVER THE NEXT 12 MONTHSTOP AREAS
Regulatory strategy
Pharmacovigilance
Regulatory operations(publishing)
Overflow submissions
Regulatory writing
Mature marketedproducts support
Regulatory CMC
Quality assurance
Labeling
In the first quarter of 2013, Optum Life Sciences surveyed 46 small, mid-size and large life science companies to gauge their regulatory outsourcing practices and plans. Companies represented a range of therapeutic areas — predominantly oncology, CNS, GI, CV and respiratory. Below is a closer look at their regulatory outsourcing activities.
O U T S O U RCI N GP R OV I D ER SARE FOUND
What regulatoryexecutives thinkabout outsourcing
HO
W
outsource 11-25% of their budget
18%
Optum Life Sciences
