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TRIAL FORM SUPPORT SL

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Barcelona, ES

About TRIAL FORM SUPPORT SL

For comprehensive, clinical development services, TFS offers the highest level of competence, experience and personal attention to ensure we achieve the best results for our customers. With our suite of offerings, our customers' clinical trials will be handled with care and expertise.

TFS is in the... Show more »

For comprehensive, clinical development services, TFS offers the highest level of competence, experience and personal attention to ensure we achieve the best results for our customers. With our suite of offerings, our customers' clinical trials will be handled with care and expertise.

TFS is in the business of improving and refining the delivery of better healthcare outcomes to ensure our customers' successes. We genuinely believe that being GLOBAL IN MIND AND LOCAL AT HEART is the core of our success; our customers know TFS' in-depth knowledge about regulatory and clinical trial requirements in every country, ensures a global trial will move faster to market and result in shorter timelines to get treatments to the patients who need them.

Selected Publications

  • Mearín F., Plazas M., Mas M., Heras J., Cardiac safety of cinitapride, Gastroenterología y Hepatología
  • Portincasa P., Mearin F., Robert M., Plazas M., Mas M., Heras J., Efficacy and tolerability of cinitapride in the treatment of functional dyspepsia and delayed gastric emptying. Gastroenterología y Hepatología
  • Blanco M., Prieto M., Mearin F., Plazas M., Armengol S., Heras J., Mas M., Piqué J.; el Grupo del Estudio LAN/41/01., Evaluation of preferences in patients with gastroesophageal reflux disease and dysphagia concerning treatment with lansoprazole orally disintegrating tablets. Gastroenterología y Hepatología
  • Anguita M, Castro Beiras A, Cobo E, Coca A, De Teresa E, Díez J, López B, Muñoz-Tudurí M, Cebollada J, Díaz B, Galve E, González-Juanatey JR, Jiménez-Navarro M, López I, Lupón J, Martín C, Monserrat L, Narejos S, Pascual Figal DA, Pérez-Calvo JI, Querejeta R, Ridocci F, Rodríguez A, Rodríguez M, Roig E, Roure J, Ruiz S, Sánchez PL, Terns M, Torán P., Effects of prolonged-release torasemide versus furosemide on myocardial fibrosis in hypertensive patients with chronic heart failure: a randomized, blinded-end point, active-controlled study. Clinical Therapeutics
  • Lanas A, Plazas MA, Gimeno E, Muñoz-Tudurí M., Gastroprotection in NSAID and low-dose aspirin users: a cross-sectional study in primary care. Gastroenterología y Hepatología
  • Ferrés J., Justicia J., García M., Muñoz-Tudurí M., Alvà V., Efficacy of high-dose sublingual immunotherapy in children allergic to house dust mites in real-life clinical practice. Allergologia et Immunopathologia
  • Andre S. Nell, Eva D’lom, Patrick Bouic, Montserrat Sabaté, Ramon Bosser, Jordi Picas, Merce Amat, Gavin Churchyard, Pere-Joan Cardona, Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI: Randomized, Placebo-Controlled Phase II Clinical Trial in Patients with Latent Tuberculosis Infection. Plos One
  • C. Ferrándiz, M.J. Plazas, M. Sabaté, R. Palomino, Prevalence of actinic keratosis among dermatology outpatients in Spain. Actas Dermo-Sifiliográficas
  • Otero A., Francisco A., Gayoso P., García F.; EPIRCE Study Group. & Valveny N., Prevalence of chronic renal disease in Spain: results of the EPIRCE study. Nefrología
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Our Services (24)


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Medical Device Clinical Trials

Price on request
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Quality Assurance

Price on request

TFS Quality Assurance (TFSQA), an independent group within TFS, is responsible for ensuring the quality of the work provided by TFS, and that all work is conducted in compliance with applicable GxP guidelines, relevant regulatory requirements and applicable Standard Operating Procedures (SOPs).

TFSQA is also responsible for the... Show more »

TFS Quality Assurance (TFSQA), an independent group within TFS, is responsible for ensuring the quality of the work provided by TFS, and that all work is conducted in compliance with applicable GxP guidelines, relevant regulatory requirements and applicable Standard Operating Procedures (SOPs).

TFSQA is also responsible for the TFS quality management system and conducts internal system and project audits as well as vendor audits to ensure that vendors work to the same quality standards.

The TFS auditors have many years of clinical development experience and routinely conduct GCP, Medical Device, GVP, GLP and GMP audits.

Contract audit services

TFS QA also provides contract audit services for customers and these include:

  • Vendor audits
  • System audits (e.g., pharmacovigilance and data base)
  • Study audits
  • Investigator site audits
  • Trial Master File audits
  • Document audits (e.g., protocol and study report)
  • Pre-inspection audits
  • Writing, reviewing and updating SOPs
  • Developing, reviewing and updating Quality Management Systems
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Medical Writing

Price on request

Medical writing is an integral part of clinical research. The Medical Writing Unit at TFS is fully qualified and experienced in the production of Clinical Study Protocols and Study Reports according to ICH GCP guidelines as well as a wide range of medical and scientific documentation required to support product development... Show more »

Medical writing is an integral part of clinical research. The Medical Writing Unit at TFS is fully qualified and experienced in the production of Clinical Study Protocols and Study Reports according to ICH GCP guidelines as well as a wide range of medical and scientific documentation required to support product development efforts.

TFS Medical writers are able to provide global trial support as well as specific regional/country requirements including Asia Pacific. The documentation provided by our medical writers is clearly written and compliant with all ICH guidelines and regulatory requirements, and they can be written in most European and some non-European languages.

The Medical Writing Unit also prepares documents for Medical device products.

All regulatory documents are formatted and prepared for electronic submissions.

Our services include:

  • Clinical Studies/Investigations
    • Design
    • Protocols
    • Reports
    • IMPDs/INDs/Investigator’s Brochures
  • Scientific Production
    • Bibliographic Reviews
    • Publications
    • Abstracts
    • Posters
  • Regulatory Documents
    • Preparation of documents for submission (remediation/publishing)
    • Clinical Summaries/Overviews
    • Briefing/Response Documents

TFS has Medical Writing teams based in the US and Europe.

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Pharmacovigilance and Post-Authorization Safety Studies (PASS)

Price on request

The Drug Safety Unit has extensive experience in managing all aspects of drug safety/pharmacovigilance services, from the drug development phase through to market authorization surveillance and the set-up of a pharmacovigilance system.

Our services include:

  • Set up of Pharmacovigilance system

The Drug Safety Unit has extensive experience in managing all aspects of drug safety/pharmacovigilance services, from the drug development phase through to market authorization surveillance and the set-up of a pharmacovigilance system.

Our services include:

  • Set up of Pharmacovigilance system
    • Validated Safety database
    • Electronic reporting to EudraVigilance (Certified user)
    • Safety/Pharmacovigilance consultation
  • Coding of medical terms/adverse events (MedDRA) and medications (WHO-DDE) Clinical studies
    • SAE handling, incl. assessment and narrative writing
    • Development Safety Update Report (DSUR) writing
    • Risk-Management Plan
    • Safety Review
  • Post-marketing pharmacovigilance
    • Case report handling, including assessment and narrative writing
    • Literature Searches
    • Periodic Safety Update Report (PSUR) writing
    • Signal detection
    • Pharmacovigilance System Master File (PSMF)
    • Qualified Person Responsible for Pharmacovigilance (QPPV)

TFS has Pharmacovigilance/Drug Safety teams based in the US and Europe.

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Biostatistical Analysis

Price on request

The Biostatistics unit consists of a team of experienced biostatisticians and SAS programmers managing all the statistical activities related to clinical trials.

Our validated software and computer systems are approved by regulatory authorities and are compliant with the appropriate ICH guidelines, particularly E9 (Statistical... Show more »

The Biostatistics unit consists of a team of experienced biostatisticians and SAS programmers managing all the statistical activities related to clinical trials.

Our validated software and computer systems are approved by regulatory authorities and are compliant with the appropriate ICH guidelines, particularly E9 (Statistical Principles for Clinical Trials) and E3 (Structure and Content of Clinical Study Reports), thereby enabling safe and accurate analyses. All analyses are performed using the latest applicable versions of SAS® programs.

Our services include:

  • Full service or independent biostatistical and programming support
  • Support for preliminary meetings with regulatory authorities
  • Protocol and statistical analysis plan development
  • Sample size / Power Calculations
  • Interim analyses and co-ordination of Data Safety Monitoring Boards
  • Preparation of integrated summaries of safety and efficacy for regulatory submissions to the FDA and EMA
  • Randomization services (IVRS/IWRS)
  • Preparation and review of essential study documents (CSP, CIP, SAP, CSR, CIR*)
  • Preparation (programming) of tables, listings and/or graphs
  • Input to publications and assistance in answering editor comments
  • Mapping of old studies to CDISC** format (SDTM, ADaM***)

*Clinical Study Protocol, Clinical Investigation Plan, Statistical Analysis Plan, Clinical Study Report, Clinical Investigation Report

** Clinical Data Interchange Standards Consortium

*** Study Data Tabulation Model, Analysis Data Model

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Clinical Data Management

Price on request

The Clinical Data Management unit efficiently manages all aspects of data handling in accordance with the protocol, the data management plan, efficient data capture, accurate data and timely completion of the clinical database.

TFS has many years of experience working with clinical data management utilizing a broad knowledge of... Show more »

The Clinical Data Management unit efficiently manages all aspects of data handling in accordance with the protocol, the data management plan, efficient data capture, accurate data and timely completion of the clinical database.

TFS has many years of experience working with clinical data management utilizing a broad knowledge of different electronic data capture tools and paper-based trials. TFS clinical databases and software are validated in compliance with European, ICH and FDA standards.

Our Services include:

  • Full service data management support
  • eCRF and paper design
  • Data Management Documentation (DMP, DVP, DMR, etc.)
  • Database set-up, Data Entry, Medical Coding, Data Validation and Cleaning
  • Reconciliation of lab, ECG, imaging data, etc.
  • SAE reconciliation
  • Support and training of investigators and monitors
  • Data Transfers
  • System Validation
  • Flexible data capture techniques across major EDC platforms
  • Databases are constructed according to CDASH (CDISC)

TFS has clinical data management teams based in the US and Europe offering customers cost effective and flexible EDC technology, including OmniComm and Trial-on-Line

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Patient Recruitment

Price on request

TFS offers a proven process for rapid patient recruitment without compromising results. With access to a worldwide network of KOLs and investigational sites in a broad range of therapeutic areas TFS’ dedicated Recruitment Services Team handles every aspect of patient recruitment from placing advertisements to the initial patient... Show more »

TFS offers a proven process for rapid patient recruitment without compromising results. With access to a worldwide network of KOLs and investigational sites in a broad range of therapeutic areas TFS’ dedicated Recruitment Services Team handles every aspect of patient recruitment from placing advertisements to the initial patient screening.

TFS operates a call center, with multilingual, medically qualified operators supported by experienced project leaders who manage the entire process and ensure timelines are met.

Our services include:

Advertising

TFS knows what type of ads and media to use to generate best patient responses in each individual country and therapeutic area. Our proven recruitment process has shown high response rates and timely recruitment progress using phone, e-mail or web based communication tools.

Pre-screening

TFS’ call centers are responsible for the initial patient screening using carefully designed pre-screening questionnaires. Once a patient qualifies for the trial, they are scheduled for a screening visit with a physician at an investigational site in close proximity to where they live.

Final Selection

The ultimate patient selection is the responsibility of the trial investigator. The initial pre-screening already performed by the TFS Recruitment Team, makes the final screening on site by the clinician time efficient and enhances high-quality patient selection and timely recruitment.

TFS patient recruitment services can be contracted as a stand-alone service or as part of a full service project.

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Clinical Trial Management

Price on request

TFS Site Coordinators are GCP certified and become an essential part of the investigator’s team managing all logistics and administrative tasks for clinical projects. The TFS Site Coordinators assure high quality trial data, assist in patient recruitment and compliance, reduce data-entry time for investigators and support... Show more »

TFS Site Coordinators are GCP certified and become an essential part of the investigator’s team managing all logistics and administrative tasks for clinical projects. The TFS Site Coordinators assure high quality trial data, assist in patient recruitment and compliance, reduce data-entry time for investigators and support successful study start-up and trial initiation.

Site Coordinator Services include:

  • Supporting investigators with patient recruitment
  • Administrative coordination of ethics committee submissions to hospitals
  • Support of the CRA during monitoring visits
  • Maintenance of the Investigator’s file
  • Coordination of patient visit schedules
  • Drug accountability and dispensing logs
  • Coordination of sample shipments
  • Payment of patient expenses
  • Supporting data entry/query resolution/SAE notification
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Feasibility Studies

Price on request

TFS’ dedicated Feasibility Team, including medical, regulatory and clinical research professionals, coordinates feasibility surveys for each clinical trial. The team assesses the specific needs of each project, performs thorough risk assessment & drives contingencies planning, which results in well thought out recommendations and... Show more »

TFS’ dedicated Feasibility Team, including medical, regulatory and clinical research professionals, coordinates feasibility surveys for each clinical trial. The team assesses the specific needs of each project, performs thorough risk assessment & drives contingencies planning, which results in well thought out recommendations and potential alternative scenarios.

For each project a Feasibility Coordinator is appointed supported by a dedicated team of local Feasibility CRAs to manage the feasibility survey in the individual countries. Based on TFS’ previous experience and broad investigator network of Key Opinion Leaders (KOLs) & Principal Investigators, the team has access to a large pool of sites to involve in study feasibilities across a broad range of therapeutic indications.

Potential investigators are contacted by phone to determine their interest for the study, followed by an initial feasibility questionnaire to asses overall feasibility of the study design. Feedback from the investigators on inclusion and exclusion criteria, co-medication, study procedures, patient recruitment etc., helps to define the project plan and potentially refine the protocol. It is this pro-active approach that helps to ensure the success of the projects performed at TFS.

The Feasibility Team will follow up and conduct in-depth telephone interviews or set up face-to-face meetings to discuss study specific topics in further detail and identify potential challenges that may jeopardize patient recruitment.

Our services and expertise include:

  • Overall assessment of incidence of the indication in specified countries
  • Analysis of competing trials & compounds in development
  • Assess country specific differences, e.g. regulatory, importation, clinical practice
  • Review of trial design by therapeutic experts
  • Design of the Feasibility Questionnaire
  • Coordination and conduct of the feasibility survey
  • Production of the data driven Feasibility report

TFS’ thorough approach towards feasibility in combination with TFS’ Patient Recruitment Services ensures selection of high performing sites and on-time patient enrolment.

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Regulatory Affairs Consulting

Price on request

The TFS Regulatory Affairs Unit offers operational and strategic consulting services and has extensive experience in managing all aspects of regulatory affairs, supporting a product from the drug development phase throughout all phases of clinical development to market authorization and product maintenance. Our senior staff offer... Show more »

The TFS Regulatory Affairs Unit offers operational and strategic consulting services and has extensive experience in managing all aspects of regulatory affairs, supporting a product from the drug development phase throughout all phases of clinical development to market authorization and product maintenance. Our senior staff offer more than 30 years of successful submission experience, interacting with regulatory agencies worldwide.

Our services include:

  • Clinical Studies
    • Global Scientific Advice
    • Preparation and submission of CTA/ITA, IND, PMA/510(k)
    • Interaction with regulatory agencies world-wide
    • Orphan Drug Designations
    • Pediatric Investigational Plans (PIPs)
    • Country-specific documentation and submissions
    • End-of-trial declarations
  • Application of Marketing Authorization
    • Preparation and submission of marketing applications (CTD, NDA, BLA, NDS, MAA and equivalents)
    • Compilation of submission files- all procedures
    • Labeling proposal
    • Readability testing
    • Parallel import
  • Product Maintenance
    • SPC/product leaflet/labeling updates
    • FASS editing
    • Variations
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Clinical Development Strategy

Price on request

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical development planning and... Show more »

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical development planning and implementation.

Our services include:

  • Scientific advice
  • Product development consulting
  • Proof of concept
  • PK/PD Modelling and simulation
  • Protocol design
  • Regulatory affairs strategy
  • Preparation and submission of CTA/ITA, IND, PMA/510(k)
  • Interaction with regulatory agencies world-wide
  • Orphan Drug Designations
  • Pediatric Investigational Plans (PIPs)
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Clinical Data Collection, Analysis and Management

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Product Development, Testing, and Packaging

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Marketing, Communication & Graphic Design Services

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Business Development Consulting

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Computational Modeling

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Editorial and Writing Services

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Biostatistics & Bioinformatics

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Product Quality Control

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Clinical Trials, Consulting, and Management

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Epidemiology, Healthcare, and Post-Authorization Studies

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Regulatory Affairs Services

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Project Management

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Clinical Research

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