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    Pharma Services Category of TFS International AB

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 Clinical Development / Phase IIb-IV (1)

    02 Compliance, Regulatory & Consulting (9)

    03 Core / Central Lab (1)

    04 Medical Writing & Language Translation (3)

    05 Patient / Investigator Recruitment (3)

    06 Post Marketing (2)

    07 Technology / Data / Analytics (4)

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    01 TFS International AB (23)

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    01 Sweden (23)

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    TFS International AB

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      PRODUCT DEVELOPMENT CONSULTING

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      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

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      Pharma Service: Clinical Trials

      Category: Compliance, Regulatory & Consulting

      Sub Category: Consulting Services
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        PK / PD MODELLING & SIMULATION

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        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

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        Pharma Service: Clinical Trials

        Category: Clinical Development / Phase IIb-IV

        Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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        TFS International AB

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          PROTOCOL DESIGN

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          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

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          Pharma Service: Clinical Trials

          Category: Compliance, Regulatory & Consulting

          Sub Category: Clinical Trial Design
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            REGULATORY AFFAIRS STRATEGY

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            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

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            Pharma Service: Clinical Trials

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            Sub Category: Regulatory Affairs
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              PREPARATION & SUBMISSION OF CTA/ITA, IND, PMA / 510 (K)

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              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

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              Pharma Service: Clinical Trials

              Category: Compliance, Regulatory & Consulting

              Sub Category: Quality & Compliance
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                INTERACTION WITH REGULATORY AGENCIES WORLD-WIDE

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                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

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                Pharma Service: Clinical Trials

                Category: Compliance, Regulatory & Consulting

                Sub Category: Regulatory Affairs
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                  ORPHAN DRUG DESIGNATIONS

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                  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

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                  Pharma Service: Clinical Trials

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                  Sub Category: Regulatory Affairs
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                    PEDIATRIC INVESTIGATIONAL PLANS (PIPS)

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                    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

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                    Pharma Service: Clinical Trials

                    Category: Compliance, Regulatory & Consulting

                    Sub Category: Consulting Services
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                      END-OF-TRIAL DECLARATIONS

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                      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

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                      Pharma Service: Clinical Trials

                      Category: Post Marketing

                      Sub Category: Pharmacovigilance / Product Lifecycle Management
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                        INVESTIGATOR RECRUITMENT & SITE MANAGEMENT

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                        At TFS we strive to ensure costs are kept within the budget using our in-depth knowledge of international and local regulatory requirements and our network of global investigators to ensure that the trial objectives will be met on time.

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                        Pharma Service: Clinical Trials

                        Category: Patient / Investigator Recruitment

                        Sub Category: Patient Recruitment
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                          CLINICAL MONITORING

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                          At TFS we strive to ensure costs are kept within the budget using our in-depth knowledge of international and local regulatory requirements and our network of global investigators to ensure that the trial objectives will be met on time.

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                          Pharma Service: Clinical Trials

                          Category: Technology / Data / Analytics

                          Sub Category: Clinical Trial Monitoring
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                            GLOBAL QA & COMPLIANCE

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                            At TFS we strive to ensure costs are kept within the budget using our in-depth knowledge of international and local regulatory requirements and our network of global investigators to ensure that the trial objectives will be met on time.

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                            Pharma Service: Clinical Trials

                            Category: Compliance, Regulatory & Consulting

                            Sub Category: Quality & Compliance
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                              PATIENT RECRUITMENT SERVICES

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                              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

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                                FULL SERVICE DATA MANAGEMENT SUPPORT

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                                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.

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                                Pharma Service: Clinical Trials

                                Category: Technology / Data / Analytics

                                Sub Category: Data Management
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                                  ECRF & PAPER DESIGN

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                                  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.

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                                  Pharma Service: Clinical Trials

                                  Category: Medical Writing & Language Translation

                                  Sub Category: Clinical Research Translation / Validation
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                                    DATA MANAGEMENT DOCUMENTATION (DMP, DVP, DMR, ETC.)

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                                    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.

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                                    Pharma Service: Clinical Trials

                                    Category: Technology / Data / Analytics

                                    Sub Category: Data Management
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                                    TFS International AB

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                                      DATA ENTRY & MEDICAL CODING

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                                      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.

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                                      Pharma Service: Clinical Trials

                                      Category: Medical Writing & Language Translation

                                      Sub Category: Clinical Research Translation / Validation
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                                        RECONCILIATION OF LAB, ECG, IMAGING DATA, ETC.

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                                        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.

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                                        Pharma Service: Clinical Trials

                                        Category: Core / Central Lab

                                        Sub Category: Clinical & Medical Imaging
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                                        TFS International AB

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                                          SUPPORT & TRAINING OF INVESTIGATORS & MONITORS

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                                          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.

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                                          Pharma Service: Clinical Trials

                                          Category: Patient / Investigator Recruitment

                                          Sub Category: Patient Recruitment
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                                            BIOSTATISTICS

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

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                                            Pharma Service: Clinical Trials

                                            Category: Technology / Data / Analytics

                                            Sub Category: Clinical Biostatistics and Programming
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                                              PHARMACOVIGILANCE & DRUG SAFETY

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                                              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.

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                                              Pharma Service: Clinical Trials

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                                              Sub Category: Pharmacovigilance / Product Lifecycle Management
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                                                MEDICAL WRITING

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                                                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

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                                                Pharma Service: Clinical Trials

                                                Category: Medical Writing & Language Translation

                                                Sub Category: Clinical Research Translation / Validation
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                                                  QUALITY ASSURANCE

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                                                  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).

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                                                  Pharma Service: Clinical Trials

                                                  Category: Compliance, Regulatory & Consulting

                                                  Sub Category: Quality & Compliance
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