2. TABLE OF CONTENTS
1. About ‘XERTZ’ ................................................................................................3
2. Why ‘XERTZ’ ..................................................................................................3
3. Services snapshot..............................................................................................3
3.1. Pharmacovigilance..................................................................................4
3.2. Clinical Data Management....................................................................5
3.3. Medical Writing .....................................................................................6
4. Contact us: ........................................................................................................7
3. 1. Abou
X
H
O
b
X
2. Why
X
3. Serv
ut ‘XERTZ’
XERTZ – a Heal
Healthcare Ind
Our “right” skil
best services to
XERTZ is comm
y ‘XERTZ’
XERTZ service
Better unde
Alignment o
Cost effectiv
Open comm
Process con
Performanc
vices snapshot
• AE and SAE ev
• MedDRA and W
• SAE narrative w
• Causality and L
• Physician medi
detection.
• Literature review
• Updating CCDS
documents
• Security and Sa
per 21 CFR par
• Expedited Repo
of MedWatch 35
lthcare and Pha
ustry through c
lled resources,
o our clients an
mitted to provid
team has over
erstanding of sc
of process towa
ve operational
munication and
ntrol and best w
ce tracking and
t
valuations
WHO-DD Coding
writing and Medical
Labeling Assessme
cal review and sign
ws and summaries
S and other Core
afety of data manag
rt 11.
orting (ICSR): Gene
500A/CIOMS I form
arma services o
committed and
enhanced proc
nd differentiate
de better caree
10+ years of ex
copes and serv
ards client need
model
customer enga
work flow
d continuous im
writing
nts.
nal
.
ged as
eration
ms
organization de
d reliable servic
cessing techniq
s us in the grow
r for the Health
xperience in th
vices
ds
agement
mprovement
• Project man
• CRF/ eCRF
• Database b
• Data entry &
• Discrepanc
• External D
device data,
• AE/Con Me
• Quality Rev
• Archival & d
Migration.
• Security an
per 21 CFR
edicated to serv
ces.
ques, excellent q
wing market.
hcare Professio
he industry and
nagement & Protoc
F design
built, design & prog
& Validation
cy Management
ata Handling (SAE
, etc)
ed/Disease coding
view & reconciliatio
documentation / Da
d Safety of data ma
R part 11.
ve the need of
quality and tur
onals and empa
d has served clie
col review
ramming.
E, labs,
n
ata
anaged as
Pharma and
rnaround time h
athetic service t
ents in various
• Synopsis
• Protocols
• Clinical Study
• Clinical section
• Informed Cons
• Investigator s
• Periodic / Agge
helps us to deli
to our custome
specialties and
Repor ts
ns of CTD
sent Document
brochure etc.,
ergate safety writin
iver the
ers.
d scopes.
ng
4. 3.1. Pharmacovigilance
Best in class technical team.
Over 10 years of experience in the areas of
Pharmacovigilance/Drug Safety.
Security and Safety of data managed as per
Regulatory standards (Part 11, HL7, etc).
Inform, Argus Safety, @ris global, WHODD,
MedDRA, etc., expertise.
6 years of average experienced professionals as
trainers, supervisors and Project leads.
Coders experienced in working on multiple coding
platforms.
Handled submissions across the Globe.
Our average associate experience is about 3 years
Best in class QA with accuracy rates 98%+
Specialties
o Neurology
o Oncology
o Ophthalmology
o Cardiovascular
o Dermatology
o Hematology
o Infectious Diseases
o Urology
o Respiratory
o Endocrinology, etc.,
Medical Analysis
• AE and SAE evaluations.
• MedDRA and WHO‐DD Coding.
• SAE narrative writing and Medical writing.
• Causality and Labeling Assessments.
• Physician medical review and signal detection.
• Literature reviews and summaries.
• Updating CCDS and other Core documents.
Regulatory Reporting
• Expedited Reporting (ICSR): Generation of MedWatch
3500A/CIOMS I forms
• Preparation of periodic/aggregate safety reports
• Prompt notification of potential expedited IND, alert,
and suspected unexpected serious adverse reaction
(SUSAR) reports via E2B and Paper mail.
5. 3.2. C
Best
Over
areas
Mana
and C
Secur
mana
stand
Oracl
etc.,
6 yea
profe
supe
Team
to ha
obsta
abilit
Hand
Trial
Quali
We o
servi
elect
trials
The C
deliv
data
solut
and r
best
Flexi
as we
End‐
Euro
Clinical Data
in class CDM te
r 10 years of ex
s of Clinical Dat
agement, DB de
CRF designing.
rity and Safety
aged as per Reg
dards (Part 11,
le Clinical, WH
ars of average e
essionals as tra
rvisors and Pro
m is equipped w
andled tight dea
acles, Problem
ties etc.,
ds on experienc
s and Research
ity to the core.
offer a full spect
ices for paper‐b
tronic data capt
s using the app
CDM specialists
ver the Quality S
concerns. That
tions for all you
resources you n
for you, and yo
bility to use ou
e have expertis
‐User Focused
pean Directive
a Manageme
eam.
perience in the
ta
evelopment
of data
gulatory
HL7, etc).
ODD, MedDRA,
experienced
ainers,
oject leads
with skill sets
adlines, face
solving
ce on Global
h Studies.
trum of CDM
based and
ture based
ropriate and se
s at XERTZ kno
Services on tim
t’s why we go o
ur CDM needs, b
need to make T
our project.
ur clients’ propr
se in most of th
d Approach: W
e 2001/20/EC g
ent
e
,
ecure applicatio
ow what a chall
me, and to ident
out of our way n
but to also prov
TIMELY decisio
rietary or licen
he safety databa
e follow the ICH
guidelines and
ons.
lenging task it c
tify and solve e
not only to offe
vide you with t
ons about which
nsed electronic
ases.
H Efficacy guid
focus our work
can be to build
ven the simple
er comprehensi
the information
h solutions are
reporting syste
delines, FDA's G
k‐products on t
and
est of
ive
n
ems
Good Pharmaco
the end‐user pe
ovigilance Pract
erspective.
Paper based stud
EDC
tices and EMEA
dies
A's
