This document discusses CDISC standards for representing survival data from oncology clinical trials. It provides an overview of CDISC and describes the SDTM and ADaM domains that are useful for capturing efficacy endpoints involving survival, such as overall survival, progression-free survival and tumor response. Examples are given of how survival data from different patients would be represented in an ADTTE (Analysis Dataset for Time to Event) dataset according to CDISC ADaM standards.

1. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]
CDISC SDTM and ADaM
for survival data
VI BIAS Annual Conference
Analisi della sopravvivenza ed applicazioni in Oncologia:
un percorso dalle basi agli ultimiaggiornamenti
Genoa – 30-31/10/2014
Angelo Tinazzi
Cytel Inc., Wilmington Del. USA
Succursale de Meyrin – Geneva – Switzerland
angelo.tinazzi@cytel.com
1

2. Cytel Inc. - Confidential
[A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]
2
The information contained in this
presentation is based on personal
research of the author and does not
necessarily represent Cytel Inc.

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CDISC Intro
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
CDISC is a global, open, multidisciplinary, non-profit
organization that has established standards
to support the acquisition, exchange, submission
and archive of clinical research data and
metadata.
The CDISC mission is to develop and support
global, platform-independent data standards
that enable information system
interoperability to improve medical research
and related areas of healthcare. CDISC
standards are vendor-neutral, platform-independent
and freely available via the CDISC
website.

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CDISC Intro
Available Standards
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC Intro
Standards in Submission
Data
Analysis
Data
Tabulations
Data
Collection
Planning
SDTM ADaM
SEND
CDASH
LAB
Protocol
Study
Design
NCI CT
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC Intro
A World of Clinical Standards
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC Intro
Traceability
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
Primary Overall Survival Analysis
ADTTE
ADaM define.xml
DM
aCRF
SDTM define.xml

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Efficacy Endpoints in Oncology
Solid Tumors
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
Clinical Trial
Endpoint
Definition Source
Overall Survival
(OS)
Time from randomization to death from any cause. FDA
Objective
Response Rate
(ORR)
Proportion of patients achieving either a partial or
complete response for a minimum duration of time.
FDA
Disease-free
survival (DFS)
Time from randomization until recurrence of tumor
or death from any cause. DFS is typically used in
clinical trials of adjuvant cancer therapy.
FDA
Progression-free
survival (PFS)
Time from randomization until objective tumor
progression or death.
FDA
Time to
progression (TTP)
Time from randomization until objective tumor
progression (does not include deaths)
FDA
Time to treatment
failure (TTF)
Time from randomization to treatment
discontinuation for any cause, including drug
toxicity.
FDA
Progression-free
survival 2 (PFS2)
Same as PFS with some indication variant. E.g. in
Prostate cancer
-
Duration of
Response (DOR)
Time from documentation of tumor response to
disease progression
EMA
Clinical Benefit
Response Rate
(CBR)
Patients achieving either a complete response,
partial response or absence of progression at 6
months
EMA

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Efficacy Endpoint in Oncology
Solid Tumors
RAN SD SD PR CR PD
DOR
ORR
OS
PFS TTP
Death /
Alive
TTF
Off TRT
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC SDTM
SDTM Domains (as per Version 3.2)
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC SDTM
Domains/Items Useful for Overall Survival
Date of Origin / Starting point
Randomization date
Treatment Start date
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
DS
DM

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CDISC SDTM
Domains/Items Useful for Overall Survival
Date of death
DM
DS
Patient 101001 died (DTHFL=Y) the 17JAN2013 (DTHDTC)
Patient 101006 is alive (DTHFL=NULL)
Patient died (DSSCAT=REPORT OF DEATH) because of Progressive Disease (DSTERM) on
14DEC2010 (DSSTDTC)
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC SDTM
Domains/Items Useful for Overall Survival
Date of last follow-up
 Any date documenting patient is still alive
 Visit date, AEs, CM, Lab Samples, ECG, etc.
 In SDTM we have a lot of «administrative» date that should be
not considered (--DTC)
 Investigate for date in Supplemental Qualifiers
SUBJID SSORRES SSSTR
ESC
VISIT SSDTC
001001 ALIVE ALIVE FUP 1 07JAN13
001001 ALIVE ALIVE FUP 2 25MAY13
001002 DECEASED DEAD FUP 1 08JUN13
001003 ALIVE ALIVE FUP 1 01JAN12
001003 ALIVE ALIVE FUP 2 05AUG12
001003 PATIENT LOST
TO FOLLOW UP
LOST FUP 3 20NOV12
Last follow-up
Date when death was reported.
Date of death in DM
At this follow-up the patient was
known to be lost, date of last
follow-up is therefore 05AUG12
(previous visit)
Survival SS Status (available from version 3.2)
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC SDTM
OncologyDomains for Tumor Response TU/TR/RS
Tumor Identification
Unique identification of tumors for that patient
Tumor Results
Quantitative measurements and/or qualitative
assessments of the tumors identified in the TU
Disease Response
Clinical response evaluations determined from the TR
data and other SDTM domains
TU
TR
RS
 Overcoming Difficulties in Implementing RECIST criteria, PhUSE 2013, G. Ruhnke
 CDISC Journey on Solid Tumor Studies using RECIST 1.1., PhUSE 2013, K. Lee
 SDTM Oncology Domains From Patients to Data to Narrative, PhUSE 2013, K. Stoltzfus
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC SDTM
OncologyDomains for Tumor Response TU/TR/RS
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC SDTM
OncologyDomains for Tumor Response TU/TR/RS
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC SDTM
OncologyDomains for Tumor Response TU/TR/RS
Source: Oncology Legacy Data => SDTM.
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC ADaM
FoundationModels
• One record per subject
• Demographics, Baseline Chars
• Study Population (ITTFL, SAFFL, ..)
• Study Arm, Treatment Periods
ADSL
Analysis Subject Level
Dataset
• Vertical Structure
• One or more record per subject/time-point
BDS
Basic Data Structure
• Counting of subjects with a record for
each term
• It often includes a structured
hierarchy of dictionary
ODS
Occurrence Data
Structure
• Based on BDS
• Time to the Event of Interest
• One or more time-to-event endpoint
per ADTTE dataset
TTE
Time to Event
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC ADaM
ADTTE – Analysis Dataset for Time to Event – Variables of Interest
 Description of time-to-event (PARAMCD/PARAM)
 E.g. OS/Overall Survival
 Date Origin (STARTDT)
E.g. Randomization Date
 Censor (CNSR) 0=Event
 Analysis date of event or censoring (ADT)
 E.g. Death Date / Last follow-up
 Elapsed time to the event of interest from the origin
(AVAL)
 E.g. (ADT-STARTDT)+1 (days)
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC ADaM
ADTTE – Analysis Dataset for Time to Event – Variables of Interest
 Event or Censoring Description (EVNTDESC)
 E.g. DEATH
 Censor Date Description (CNSDTDSC)
 E.g. LAST FOLLOW-UP DATE
 Imputation Date Flag (ADTF)
 E.g. D/M/Y
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

21. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]
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ADTTE Examples
Case 1: Single Endpoint with Multiple Values for Censoring
A studywith Overall Survival as Primary Endpoint
Definition Time from randomization until death
from any cause
Censor Last date subject was seen alive
Cut-off Date Applied: 08APR2014
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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ADTTE Examples
Case 1: Single Endpoint with Multiple Values for Censoring
SUBJID TR
TP
PARA
MCD
PARAM AVAL START
DT
ADT A
D
T
F
C
N
S
R
EVNTDESC
001001 PBO OS Overall Survival
(Months)
16.8 15AUG11 07JAN13 0 DEATH
001002 EXP OS Overall Survival
(Months)
8.4 12SEP11 25MAY12 D 1 LAST FOLLOW-UP
DATE
001003 EXP OS Overall Survival
(Months)
7.2 02SEP13 08APR14 1 FINAL
ANALYSIS CUT-OFF
DATE
Endpoint: Overall Survival ; Cut-off Date Applied: 08APR2014
Treatment
Received
Time to Event
Parameter
− Start Date Randomisation
- Event/Censor Date
Time part of the TTE event
(ADT-STARTDT+1)/30.42
*30.42 Standard for nr. of days in a month
Event/Censor
Description
0=Event
1..n=Censor
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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ADTTE Examples
Case 1: Single Endpoint with Multiple Values for Censoring
SUBJID TR
TP
PARA
MCD
PARAM AVAL START
DT
ADT A
D
T
F
C
N
S
R
EVNTDESC
001001 PBO OS Overall Survival
(Months)
12.1 01APR13 07JAN13 0 DEATH
001002 EXP OS Overall Survival
(Months)
17.2 04APR13 25MAY12 D 1 LAST FOLLOW-UP
DATE
001003 EXP OS Overall Survival
(Months)
17.5 08APR13 08APR14 1 FINAL
ANALYSIS CUT-OFF
DATE
Endpoint: Overall Survival ; Cut-off Date Applied: 08APR2014
A partial date (--MAY12) where the day part has been imputed. Valid values are D,M,Y
More details about censoring date. This patient either die or had a follow-up>cut-off date
and therefore censored at the time of analysis cut-off date
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
This is also traceability!!!!!!

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ADTTE Examples
Case 1: Single Endpoint with Multiple Values for Censoring
Endpoint: Overall Survival ; Cut-off Date Applied: 08APR2014
SUBJ
ID
TR
TP
PARA
MCD
… ADT A
D
T
F
CN
SR
EVNTDESC SRC
DOM
SRCVAR SRCS
EQ
001001 PBO OS … 07JAN13 0 DEATH DM DTHDTC .
001002 EXP OS … 25MAY12 D 1 LAST FOLLOW-UP
DATE
ADSL LASTVSDT .
001003 EXP OS … 08APR14 1 FINAL
ANALYSIS
CUT-OFF DATE
ADSL LASTVSDT .
SDTM.DM ADAM.ADSL
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
This is also traceability!!!!!!

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ADTTE Examples
Case 2: Composite Endpoint with multiple value for Event and Censoring
Progression Free Survival
Definition Time from randomization until radiological
tumor progression or death which ever come
first
Censor Last date radiological tumor assessment
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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ADTTE Examples
Case 2: Composite Endpoint with multiple value for Event and Censoring
Endpoint: Progression Free Survival
SUBJ
ID
T
R
T
P
PA
RA
MC
D
PARAM AVAL START
DT
ADT C
N
S
R
EVNTDESC CNSDTDSC
001001 P
B
O
PFS Progression
Free
Survival
(Months)
16.8 15AUG11 07JAN13 0 RADIOLOGI
CAL
PROGRESSI
ON
001002 E
X
P
PFS Progression
Free
Survival
(Months)
8.4 12SEP11 25MAY12 1 STUDY
COMPLETED
LAST
RADIOLOGIC
AL
ASSESSMENT
001003 E
X
P
PFS Progression
Free
Survival
(Months)
7.2 02SEP13 08APR14 2 NO
BASELINE
ASSESSMEN
T
RANDOMIZAT
ION
001004 P
B
O
PFS Progression
Free
Survival
(Months)
8.4 12SEP11 25MAY12 0 DEATH
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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ADTTE Examples
Case 3: One ADTTE with several time-to-event Endpoints
 Phase III study
 First Relapsed or Refractory Acute Myeloid
Leukemia
 Primary Endpoint: Overall Survival
 Sensitivity Analysis
 Overall Survival censored for Susbsequent AML Therapies
 Overall Survival censored for Post Treatment
Transplantation
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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ADTTE Examples
Case 3: One ADTTE with several time-to-event Endpoints
SUBJ
ID
T
R
T
P
PAR
AMC
D
PARAM AVAL ADT C
N
S
R
EVNTDESC CNSDTDSC
001001 P
B
O
AML Susbsequent AML
Therapies (Months)
0.6 31AUG11 0 SUBSEQUENT
AML NON
PROTOCOL
THERAPY
001001 P
B
O
TRA Post Treatment
Transplantation
(Months)
16.8 07JAN13 1 NO EVENT LAST VISIT
DATE
001001 P
B
O
OS Overal Survival
(Months)
16.8 07JAN13 0 DEATH
001001 P
B
O
OST
R
OS Censored for
Transpl. (Months)
16.8 07JAN13 0 DEATH
001001 P
B
O
OSA
ML
OS Censored for
Subsequent AML
Therapy (Months)
0.6 31AUG11 1 NO EVENT SUBSEQUENT
AML NON
PROTOCOL
THERAPY DATE
The Subsequent AML therapy started on 31st August 2011. The death occurred the 7th
January 2013 was censored for OSAML
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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ADTTE Examples
ADaMDefine.xml
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
Variable Value Label Type Format Source/Computational Method
PARAMCD PFS Progression
Free Survival
(Months)
FLOAT 8.1 Analysis Date (ADT) used for Progression
Free Survival will be the earliest date of
radiologically documented disease
progression (RS.RSDTC where
RS.RSTESTCD=OVRLRESP and
RSORRES=PD) or death (DM.DTHDTC)
If none of these events occurred Analysis
Date (ADT) is the last post-baseline
tumour assessment (Max RS.RSDTC).
Progression Free Survival (months)=(ADT
- STARTDT+1)/30.42

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ADTTE Examples
Analysis ResultsMetadata
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References
Analysis Results Metadata
Fields
Description
Display Identifier Tables 14.2.1
Display Name Overall Survival (months) by Treatment
Result Identifier Overall Survival (months)
PARAM Overall Survival (months)
PARAMCD OS
Analysis Variables AVAL, CNSR
Reason Primary Efficacy Endpoint as per Protocol
Dataset ADTTE
Selection Criteria ITTFL=‘Y’ and PARAMCD=‘OS’
Documentation SAP Section 10.1.1
Programming Statements PROC LIFETEST DATA=ADTTE;
TIME AVAL*CNSR(1);
STRATA TRTP;
WHERE PARAMCD=‘OS’;
RUN;

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ADTTE Examples
The Analysis Reviewer Guide: The ideal place where to clarify
potential source of misinterpretation not enough explained in the SAP
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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References
RECIST and OTHER NON SOLID TUMOR REFERENCES
 P Therasse et al, "New response evaluation criteria in solid tumors: Revised
RECIST guideline (version 1.1)," European Journal of Clinical Oncology, pp.
45: 228-247, 2009.
 Overcoming Difficulties in Implementing RECIST criteria, PhUSE 2013, G.
Ruhnke
 CDISC Journey on Solid Tumor Studies using RECIST 1.1., PhUSE 2013, K.
Lee
 SDTM Oncology Domains From Patients to Data to Narrative, PhUSE 2013, K.
Stoltzfus
 D Cheson et al, "Revised Recommendations of the International Working
Group for Diagnosis, Standardization of Response Criteria, Treatment
Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid
Leukemia," Journal of Clinical Oncology, pp. Vol 21, No 24: pp 4642-4649,
2003
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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References
ONCOLOGY RELATED REGULATORY GUIDANCE
 Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Cancer
Drugs and Biologics, FDA, 2011
 Cancer Drug Approval Endpoints
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResourc
es/CancerDrugs/ucm094586.htm
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

34. Cytel Inc. - Confidential [A. Tinazzi – CDISC SDTM and ADaM for survival data – BIAS 2014 Genoa 30-31 October 2014]
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CDISC SDTM
 CDISC Standards
References
 CDISC Study Data Tabulation Model (SDTM) v1.4
 Study Data Tabulation Model Implementation Guide (SDTMIG) v3.2
 Associated Persons Implementation Guide (SDTMIG-AP) v1.0
 Released Therapeutic Area Standards:
 Diabetes, Alzheimer, Asthma, Multiple Sclerosis, Pain, Parkinson Disease, Polycystic Kidney Disease,
Tuberculosis and Virology
 Oncology for Tumor Response domains (integrated into SDTMIG 3.1.3)
 CDISC/NCI-EVE Standard Controlled Terminology
 FDA Guidance and Technical Documents:
 CDER and CBER: Guidance for Industry - Providing Regulatory Submissions in Electronic Format -
Standardized Study Data (Draft)
 Study Data Specifications (soon replaced by Study Data Technical Conformance Guide)
 CDER Common Data Standards Issues
 C Holland J Shostak - Implementing CDISC Using SAS, SAS 2012
 F Wood - Creating SDTM Datasets from Legacy Data - PharmaSUG - 2011
 A Tinazzi - Looking for SDTM Migration Specialist – PhUSE - London 2014
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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CDISC ADaM
References
 Analysis Data Model (ADaM) Implementation Guide v1.0
 The ADaM Basic Data Structure for Time-to-Event Analyses v1.0
 Analysis Data Model (ADaM) Data Structure for Adverse Event Analysis
 G Cappellini - ADaM and traceability: Chiesi experience. BIAS Seminar «Data
handling and reporting in clinical trials with SAS» - Milan 2013
 A Tinazzi - Interpreting CDISC ADaM IG through Users Interpretation. PhUSE -
Bruxelles 2013
CDISC Intro
Efficacy Endp. Onco
CDISC SDTM
CDSIC ADaM
ADTTE Examples
References

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Thank you for your time!
Angelo Tinazzi – Associate Director – Statistical Programming
angelo.tinazzi@cytel.com

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Cytel Global Reach
USA
• Cambridge, MA
(HQ)
• Philadelphia, PA
• Waltham, MA
Sales Offices
• New York, NY
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office)
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• >400 FTEs worldwide
• Low turnover rate (7% in
2011, 2012)
UK
• London (sales
office)

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