full service cro - syntax for science

- 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


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


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

Syntax for Science S.L. | www.syntaxforscience.com


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


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

12

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


13

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


14

100% Transparent

Our project management

technology provides real time

updates to sponsors about the

project status:

• Tasks

• Timelines

• Responsibilities

• Workload

• GANTT


15

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


16

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”


17

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


18

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).


19

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


20

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%


21

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


22

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


https://www.youtube.com/playlist?list=PLbwOwL5HVYIf-SItOBQX3UTsMD2G6W7AI

23

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


24

Biostatistics :

• Study design

• Statistical analysis plan

• Sample size calculation

• Randomization

• Interim-analysis

• Meta-analyses

• Indirect comparisons

• PK/PD analysis


• 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

25

Medical Writing:

• Statistical technical sections: methods and results

• Clinical study reports (ICH E3)

• Clinical trial protocol writing

• Scientific papers

• Abstracts, posters and oral presentations


26

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


27

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


28

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.


WE WILL ASSIST YOU IN:

• Giving advice on drug development

• Pharmacokinetic studies and pharmacodynamic population

models

• Biostatistics analysis

• Bioequivalence studies

29

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


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

30

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 :



Some of our clients:


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!

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