- Our experience, your advantage - Full Service CRO

Transcription

1 - Our experience, your advantage - Full Service CRO

2 Small enough to care, big enough to cope We are a specialized team with a real passion for quality and improvement. EXPERIENCED TEAM FOCUSED ON CLIENTS HIGH-QUALITY SERVICES 2

3 Organization Chart

4 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 citations 4

5 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 5

6 Staff in numbers (N=42) MergeAlClini cal & Syntax (N=34) 25 (N=25) (N=17) 10 (N=8) (N=10) 5 (N=2.5) (N=3.5) (N=5) Management Project Management Biometry Clinical Operations Medical affairs IT Develop.

7 Therapeutic Areas 35 % of Projects by Therapeutic Area up to

8 Study Phases % of Projects by Phase/Type up to % 45% Phase IV National International 25 Phase III Phase II 10 5 Phase I 0 Clinical Trial Observational Diagnostic/Prognostic Study Medical Device 8

9 Therapeutic Areas No. of Projects currently active

10 Technology in use Project Management Business Management QS Documents Human Resources Management Expense Reports Documentation Management Macro Repository Protocol Deviations Training Log ecrf CRF Designer Reports CDISC Tools Single Sign-On DM/PK Modeling

11 Improvement process Standard Operating Procedures Quality Training Working Instructions Internal Audits External Audits Life Cycles Templates Forms

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 12

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 13

14 100% Transparent Our project management technology provides real time updates to sponsors about the project status: Tasks Timelines Responsibilities Workload GANTT 14

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 15

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 16

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 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 17

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 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) 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). 18

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 19

20 Traditional on-site monitoring versus centralized risk-based monitoring 100% 100% 100% 100% 5% 40% 5% 85% FDA encourages centralized risk-based monitoring. State of the art methods. International collaboration for the development of a centralized risk-based monitoring system. 20

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 21

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 22

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 23

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 24

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 25

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 26

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 27

28 Mod & Sim PK/PD We develop pharmacokinetic and pharmacodynamic population models that associate doseconcentration 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 28

29 Internal Quality System Good Clinical Practice, and 21 CFR part 11 compliance. A total of 293 QS Documents reviewed by an experienced Auditor SOP Template Form Working Instructions Others Quality System* Project Management IT Administrative Regulatory Affairs Monitoring Safety Vigilance Data Management Biostatistics Medical Writing Human Resources 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. 29

30 IT Computer System : 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 30

31 Some of our clients: 31

32 Challenge us and confirm it! 32

33 Thank you! Let s Research! PALMA DE MALLORCA ParcBit, Edif. DISSET A-2 Ctra. Valldemossa Km Palma de Mallorca Spain BARCELONA C/ Nápoles 343, Entresuelo A Barcelona Spain Tel: info@syntaxfs.com