- Our experience, your advantage -
Full Service CRO
2Syntax for Science S.L. | www.syntaxforscience.com
Small enough to care, big enough to cope
We are a specialized team with a real passion for quality and improvement.
EXPERIENCED TEAM HIGH-QUALITY SERVICESFOCUSED ON CLIENTS
Organization Chart
4Syntax for Science S.L. | www.syntaxforscience.com
Management Team
Juan V. Torres, MSc. Chief Executive Officer
Statistician with over 12 years
experience in clinical research.
Active member of the statistical
community: ISCB, SEB, and SoCE
Lidia Almirall, MSc.Chief Clinical Operations Officer
Biology Degree and MBA, with
more tan 20 years experience in
drug development.
César Garcia-Rey, MD.Chief Medical Officer
Specialist in Clinical
Microbiology with more than
15 years experience in clinical
research
Author of over 60 papers with
more than 2.000 citations
5Syntax for Science S.L. | www.syntaxforscience.com
Services Overview
❖ Study Design
❖ Regulatory Activities
❖ Project Management
❖ Site Management
❖ Pharmacovigilance
❖ Medical Consultancy
❖ Software Development
❖ Monitoring (on-site & risk-based)
❖ Data Management
❖ Medical Coding
❖ e-Data Capture (EDC)
❖ Biostatistics
❖ Medical Writing
❖ PK/PD Advice
0
5
10
15
20
25
30
35
40
45
50
2012 2013 2014 2015 2016 2017 2018 2019 2020
Management Project Management Biometry Clinical Operations Medical affairs IT Develop.
(N=3.5)(N=2.5)(N=5)
(N=8)(N=10)
(N=17)
(N=25)
(N=34)
(N=42)
MergeAlClini
cal & Syntax
Staff in numbers
7
Therapeutic Areas
29
18
15
10
65
4 43 3 3
0
5
10
15
20
25
30
35
% of Projects by Therapeutic Area up to 2017
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Study Phases
Phase I
Phase II
Phase III
Phase IV
0
5
10
15
20
25
30
35
40
45
50
Clinical Trial Observational Diagnostic/Prognostic Study Medical Device
% of Projects by Phase/Type up to 2017
55% 45%
National International
9
Therapeutic Areas
17
15
54 4
1
4
23
0
2
4
6
8
10
12
14
16
18
No. of Projects currently active
Syntax for Science S.L. | www.syntaxforscience.com
Technology in use
Protocol Deviations
Training Log
QS Documents
Macro Repository
Single Sign-On
Project Management Business ManagementHuman Resources
Management
eCRF
Expense Reports
DM/PK Modeling
Documentation
Management
CRF Designer
Reports
CDISC Tools
Standard Operating
Procedures
Working Instructions
Templates
Forms
Life Cycles
TrainingQuality
Internal Audits
External Audits
Improvement process
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Medical Consultancy:
• Scientific advice on clinical trial planning
• Recommendations for future studies/development
• Provision of therapeutic area and product training
• Benefit-risk analyses
• Clinical expert statements
• Development and update of reference product
information
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Project Management :
A Project Manager is allocated to each project with the following responsibilities:
• Primary contact per project/client
• Elaborates all study plans (i.e. Regulatory Plan, Communication plan, etc.)
• Ensures that the study is performed on budget, quality, time and by the appropriate staff at
each project stage
• Reporting project progress
• Elaborates the study specific Risk-Based Monitoring Plan
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100% Transparent
Our project management
technology provides real time
updates to sponsors about the
project status:
• Tasks
• Timelines
• Responsibilities
• Workload
• GANTT
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Accomplishment of Regulatory activities according to local
Clinical Research regulations :
The Regulatory Expert will ensure that the study follows the “Guidance for Industry E6 Good
Clinical Practice: Consolidated Guidance” (ICH GCP guidance (E6) /FDA, April 1996 and at the
local level, all applicable laws / Norms of the Health Authorities of the country / region where the
study is carried out.
Related activities:
• EC and RA approval/authorization and
required communications
Syntax for Science S.L. | www.syntaxforscience.com
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Essential documentation:
Essential documentation will be managed by the Clinical Trial Assistant (CTA) in accordance to
the “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance” (ICH GCP
guidance -E6 /FDA, April 1996):
“8.1. Essential Documents are those documents that individually and collectively permit evaluation
of the conduct of a trial and the quality of the data produced. These documents serve to
demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP
and with all applicable regulatory requirements.”
“CTA acts as a link between all team members to ensure that all administrative activitites related
to clinical trials are completed”
Syntax for Science S.L. | www.syntaxforscience.com
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Site Management activities:
Site Selection activities (performed by a monitor) will take place to ensure that the
Investigators have the qualifications and adequate resources as specified in the “Guidance
for Industry E6 Good Clinical Practice: Consolidated Guidance” (ICH GCP guidance (E6)
/FDA, April 1996.
Related activities:
• Elaboration of feasibiltity questionnaries
• Own therapeutic experts data base
• Site approach depending on Sponsor’s requirements
(direct/annonimized)
• Selection, contracts, and payments management
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Clinical Monitoring:
Monitoring activities will take place in accordance to the “Guidance for Industry E6 Good Clinical
Practice: Consolidated Guidance” (ICH GCP guidance (E6) /FDA, April 1996
5.18 Monitoring/ 1. Purpose:
The purposes of trial monitoring are to verify that:
(a) The rights and well-being of human subjects are protected.
(b) The reported trial data are accurate, complete, and verifiable from source documents.
(c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with
applicable regulatory requirement(s).
5.18.2 Selection and Qualifications of Monitors
(a) Monitors should be appointed by the sponsor.
(b) Monitors should be appropriately trained, and should have the
scientific and/or clinical knowledge needed to monitor the trial
adequately. A monitor’s qualifications should be documented.
(c) Monitors should be thoroughly familiar with the investigational
product(s), the protocol, written informed consent form and any other
written information to be provided to subjects, the sponsor’s SOPs,
GCP, and the applicable regulatory requirement(s).
Syntax for Science S.L. | www.syntaxforscience.com
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Risk-based Monitoring:
A Risk-based approach will take place in accordance to the “Guidance for Industry –Oversight
of Clinical Investigations - A Risk-Based Approach to Monitoring”/FDA, August 2013
• Risk-based monitoring approach (established in the Study Monitoring Plan)
• Fix number of monitoring visits per project (not per site)
• Flexible assignation of visits per site: Flexible assignation based on
pre-established risks
• Flexible source data verification percentage
• Flexible percentage in each visit based on pre-established risks
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Traditional on-site monitoring versus centralized risk-based monitoring
• FDA encourages centralized risk-based monitoring.
• State of the art methods. International collaboration for the development of a centralized
risk-based monitoring system.
100% 100% 100% 100% 5% 40% 5% 85%
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Clinical Data Management:
• Consulting and Implementation of Data Management Strategies
• CRF Design
• Data Validation
• Query Management
• SAE Management
• Data Entry
• CDISC Implementation
• Data consolidation and conversion (CDISC SDTM)
• Electronic Data Transfer
Syntax for Science S.L. | www.syntaxforscience.com
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Electronic Data Capture (EDC) :
• Capture Cleaner Data
• Engage Patients from their own devices (electronic patient-reported outcome, ePRO)
• Accelerate Your Research
• One single dedicated server and backup for your data
• CDASH CRF Library
• Electronic Clinical Data Management System (based on SAS)
• Investigator and monitor training material
• Risk Based Monitoring
Syntax for Science S.L. | www.syntaxforscience.com
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Medical Coding :
Dictionaries:
• WHO Drug / ATC Country Drug Registries
• MedDRA
• ICD-10
• Other dictionaries
Technology:
• Management of multiple medical coding dictionaries
• Splitting of terms
• Version control
• Traceability from verbatim to reported terms
• Fast & Accuracy
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Biostatistics :
• Study design
• Statistical analysis plan
• Sample size calculation
• Randomization
• Interim-analysis
• Meta-analyses
• Indirect comparisons
• PK/PD analysis
Syntax for Science S.L. | www.syntaxforscience.com
• Statistical Programming in SAS® of tables, listings and figures
• Mapping of old studies to CDISC format (SDTM, ADaM)
• Derived datasets
• Statistical report and appendices
• Validation or audits of stats work accomplished by others
• Meta-analyses
• Exploratory analyses
• Biomarkers validation
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Medical Writing:
• Statistical technical sections: methods and results
• Clinical study reports (ICH E3)
• Clinical trial protocol writing
• Scientific papers
• Abstracts, posters and oral presentations
Syntax for Science S.L. | www.syntaxforscience.com
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Pharmacovigilance:
• Pharmacovigilance - ICH E6: Safety Management Plan (SMP), Pharmacovigilance System
Master File (PSMF), ADR, SAE, and SUSAR reporting
• Materiovigilance - MDD 93/42/EEC, ISO 14155:2012, MEDDEV 2.7/3 SAE, and USADE reporting
• Periodic Reporting - Quarterly Reporting, APR, DSUR (E2F), and PSUR
• Signal Management Process
• Data Monitoring Safety Board (DMSB) Coordination & Communication - Stopping Rules
• Post Market Surveillance – FDA and GHTF: Incident Reporting, and Product Recall
• Medical Monitoring - safety data review, on site monitoring and 24/7 on call support
Syntax for Science S.L. | www.syntaxforscience.com
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On-line Clinical Survey:
An affordable and trustworthy online tool to conduct clinical surveys.
System Features:
• Accessibility
• Security
• Customizable design
• Affordable pricing
Our Services:
• Full support
• Helpdesk
• Result analysis
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Mod & Sim PK/PD
We develop pharmacokinetic and pharmacodynamic population models that associate dose-
concentration with the concentration-effect relationship of drugs characterizing the drug
behavior.
Syntax for Science S.L. | www.syntaxforscience.com
WE WILL ASSIST YOU IN:
• Giving advice on drug development
• Pharmacokinetic studies and pharmacodynamic population
models
• Biostatistics analysis
• Bioequivalence studies
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SOP Template Form Working Instructions Others
Quality System* 8 11 2 - 22
Project Management 2 18 22 4 -
IT 2 1 - 9 1
Administrative - 22 - 1 -
Regulatory Affairs 1 - 3 - -
Monitoring 5 - 35 2 -
Safety Vigilance 3 6 5 - -
Data Management 16 17 20 8 -
Biostatistics 7 7 2 3 -
Medical Writing 3 9 - 1 -
Human Resources - 2 8 5 -
Good Clinical Practice, and 21 CFR part 11 compliance.
A total of 293 QS Documents reviewed by an experienced Auditor
Syntax for Science S.L. | www.syntaxforscience.com
AUDITS: Two external audits (system & project audit) has been performed in June 2016 and January 2018 in two
Phase III trial managed by Syntax for Science with the result of “0” major findings.
Internal Quality System
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SECURITY AVAILABILITY TRACEABILITY QUALITY
• Password Policies
• Firewall
• Anti-Hacking System
• User Access Groups
• Anti-Theft Systems
• UPS System
(Battery)
• Backups
• On-site, hourly
• Out-site, weekly
• Remote Access
• VPN (Encrypted)
• Web (HTTPS)
• Audit Trail
• File Access
• Server Access
• Control Version – GIT
• Data
• Programs
• Documents
• 21 CFR Part 11
• GAMP 5
• Life Cycle
• Business Continuity Plan
• Risk Assessment
• Training
IT Computer System :
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31Syntax for Science S.L. | www.syntaxforscience.com
Some of our clients:
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Challenge us and confirm it!
PALMA DE MALLORCA
ParcBit, Edif. DISSET A-2
Ctra. Valldemossa Km. 7.4
07121 – Palma de Mallorca – Spain
Tel: +34 971 910 842
[email protected] | www.syntaxforscience.com
Thank you!Let’s Research!
BARCELONA
C/ Nápoles 343, Entresuelo A
08025 – Barcelona – Spain