Company Presentation

1. DataCeutics 1
SAS Statistical Programming
Functional Service Provider

2. Services
Company Information
Projects
Experience & Savings
Agenda

3. Our Services
Functional Service Provider
Clinical Programming/Statistical Programming
CDISC, SDTM, ADaM
QC/Validation
Registries/Data Requests/Macros
Migration and User Acceptance Testing (UAT)
SAS Drug Development
Staff Augmentation
85.5%
Phase I
97.4%
Phase II
98.7%
Phase III
89.5%
Phase IV
38.1%
Medical Device

4. DataCeutics
23 Years
Operating
94%
Employee Retention Rate
97
Programming Staff*
CDISC Gold Member Since 2003
SAS Partner Since 1995
FSP Remote Worker Model
Internal Recruitment By DataCeutics’ Specialist
Lean Management Structure
90% Repeat Business
*Employees, no 1099 Workers

5. Case Study 1
DataCeutics 5
194,883 Hours Worked
20% Savings
30 Submissions
20 Year Working Relationship
Supplier Preferred Status
Deep Understanding of Clients’ Systems & Procedures
Our Hourly Rate 2.1% increase (below CPI)
Full Service Provider
Clinical & Statistical Programming
Migration
Registries
0
1
2
3
4
5
0
5
10
15
20
25
Submissions
Personnel
Submissions
Programmers
Project Managers

6. 1999:
Helped Implement first
SAS Reporting SOP’s
Implemented the first
SAE System
Implemented the 25th
Protocol in the
Database
SAS and E-SUBS
integrations
2008-Ongoing:
Statistical and IT Platform Support on Multiple studies, Disease States and
Drugs
Case Study 1Timeline
DataCeutics
6
1996:
Provided Data
Management
Support and
Statistical
Programming
1997-1998:
Helped Implement
and validate the
First Standard
Clinical Data
Management
System
2002:
Executed the first R & D
MSA To Provide Clinical
Programming and SAS
Support
2005:
IT MSA to provide
IT Platform support
for Clinical Systems
2008:
Amended the
MSA to include
FSP Agreement
for Statistical
Programming
and Study
Support
19981996 2000 2002 2004 2006 2008 2010 2012 2014 2016
2008: 33 DataRequests.
2009: 57 DataRequests.
2010: 30 DataRequests and 4 Regulatory Reports.
2011: 34 DataRequests and 3 Regulatory Reports.
2012: 42 DataRequests and 4 Regulatory Reports.
2013: 48 DataRequests and 5 Regulatory Reports.
2014: 42 DataRequests, 2 Regulatory Reports and 4 manuscripts.
2015: 42 DataRequests and 4 Manuscripts.
2016: 22 DataRequests and 4 Manuscripts.
Registries
Blockbuster
Case Study 1 cont’d.

7. Case Study 2
DataCeutics 7
QC / Validation for a Multi Billion Dollar BioPharma
Assign Experienced Programmers
DataCeutics’ QC Team is Separate from Programming Team
20% Error Rate Identified Yearly
Errors, If Not Found , Will Propagate into Dependent Data
Finding Errors Early Avoids Costly Rework
Errors Found Late Question the Integrity of Your Data and May Delay Submissions
Case Study 2
0
1
2
3
4
5
6
7
8
9
10
11
12
0
10
20
30
40
50
2005-2010 2011 2012 2013 2014 2015 2016
Submissions
Personnel
Submissions
Programmers
Project Managers

8. Case Study 3
DataCeutics 8
SDTM
SDTM
QC
ADaM
ADaM
QC
Tables Figures Listings
Tables
(variations)
Figures
(variations)
Listings
(variations)
Tables
(sub)
Figures
(sub)
Listings
(sub)
Quantity 71 165 19 81 282 62 128 242 5 25 496 0 10
Hours/Task 40 40 40 40 8 8 5 4 4 2 2 2 1
Total Hours 2840 6600 760 3240 2256 496 640 968 20 50 992 0 10
Statistical Programming –Rare Disorder Company
Metrics Allow for Accuracy in Pricing Projects
Staffing Accomplished Timely through DataCeutics’ Recruitment, and Employee Retention
Case Study 3
0
1
2
3
0
10
20
30
40
50
2012 2013 2014 2015 2016
Submissions
Personnel
Submissions
Programmers
Project Managers
6 Month Data Representation

9. Experienced Programmers
DataCeutics’ Programmers Have an Average of
19 Years of Experience
59% of Employees Posses Master’s or Doctoral
Degrees
Required to Score at least 95% on the
Company’s Proprietary SAS Statistical
Programming Exam & 85% on Proprietary Oral
Communications, Writing and Grammar Exams

10. DataCeutics’ FSP Remote Model
The DataCeutics’ FSP Model Provides at least 20% Cost Savings Over Sponsor Internal
Staffing
Savings Model
1. 30.3% - Bureau of Labor Statistics, US Labor Department 4. $120/sf. @ Avg. 225 sf., Util Avg. 50% of $/sf - Aspen Risk Management Group, Integrated Business Resources, 7. MIT
2. 20% - 213% - Center for American Progress 5. 1% - 5% - Spiceworks, 6. ZDNet
3. 10% - 20% - Bersin by Deloitte via LinkedIn
On average, a Senior SAS Programmer in the US makes $120k/year
15%
30%
20%
10%
10%
5%
5%
5%
Sponsor Staffing Cost:
Taxes & Insurance
Benefits (1)
Recruiting & Onboarding (2)
Training (3)
Facilities (4)(7)
IT (5)(6)
Supplies
Management
80%
20%
DataCeutics FSP Remote Cost:
Total
Staffing
Expenses
Savings
$256,000+ $204,600

11. Q&A
Immediate Needs
Near Term Requirements
Next Steps

12. Q&A
ADDITIONAL SLIDES

13. Therapeutic Areas
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Cardiology/Vascular
Hematology
Pulmonary/Respiratory
Endocrinology
Gastroenterology
Urology
Immunology
CNS
Neurology
Oncology
Genetic Disease
Infectious Disease
Musculoskeletal
Rheumatology
Dermatology
Obstetrics/Gynecology
Ophthalmology
Pharmacology/Toxicology

14. Remote Model
Work More Hours/Day than Office Employees:
Year 2010 2011 2012 2013 2014 2015 2016
Programmers 38 41 51 65 77 86 120
DataCeutics’ Remote FSP Model Attracts High Quality Staff:
Less time lost to commuting
Less time lost to illness
Less time lost to absenteeism
Fewer Interruptions
Fewer Distractions

15. Employee Distribution

16. Retention
Sources such as Forbes, MIT, CBS Money Watch, and LinkedIn indicate turnover costs
to be anywhere from 20% - 150% per employee, including:
Recruiting Costs
Interviewing Costs
Onboarding Costs
Training Costs
Lost Knowledge
Lost Group Productivity
Overworked Remaining Personnel
20-50%
(HBR)
Average Company
Turnover for Acquisitions
and Mergers
20.3%
(Forbes 8/2014)
Average CRO Turnover
Worldwide
6%
DataCeutics’ Turnover

17. Experience & Cost Savings
Experience
Attract Highly Experienced Programmers with Enriched Backgrounds
Job Satisfaction (86%) and High Retention (94%)
Cost Savings
FSP Remote Model Saves 20-30% in Staffing Costs
Pay for Hours Worked Only (with Time and Materials )