From A to Z clinical researches

INTERVENTION AT EACH PHASE OF THE CLINICAL DEVELOPMENT

Custom innovation is written in the Pharmascan DNA that offers you a « turn-key » service (from determining the methods to the clinical report) or a service by occasional tasks by managing the studies from the most simple to the most complex.

  • FEASIBILITY STUDY

    This step allows to determine the material and human means along with the implementation and study times.

  • CREATION OF STUDY DOCUMENTS

    We write and validate research protocols.

    We submit them to the committees and competent authorities (ANSM, etc.).

    We create the study documents according to the applicable rules: Observation notebook, information sheet, consent receipt form, etc.

    Once adapted, we offer the implementation and management of an electronic observation notebook (e-CRF).

  • SELECT INVESTIGATORS / PRACTITIONERS

    Our large investigators network allow us to guarantee the quick feasibility and implementation of the studies we have been trusted with.

  • REQUIRING AUTHORIZATIONS TO COMPETENT AUTHORITIES AND TO ETHICAL COMMITTEES (IF APPLICABLE)

    Our international presence makes us close to regulatory bodies and competent authorities in many countries. When necessary, we submit and monitor the file under the best conditions.

  • STUDIES IMPLEMENTATION

    We plan studies and organize investigators/practitioners meetings in our premises, at the practitioner’s office or a place defined by the Promoter of the study.

  • COORDINATION / MONITORING / REPORTING

    Research is steered by an experienced Project Manager who is dedicated to the studied theme (TMF achievement and managing, participants’ coordination, regular communication  with the promoter of the study).

    The coordinator investigator and/or opinion leader actively participates in the study management.

    Our CRA service makes sure the data are of quality, the queries are managed and the study monitored according to the GLP. It writes the plan and the monitoring report(s). It is also in charge of the tested products’ traceability and the payment of the fees/allowances.

  • MANAGEMENT AND FOLLOW-UP OF UNDESIRABLE EVENTS

    Documentation of unwanted events is achieved according to the Good Clinical Practices in relation with the investigator physicians.

  • DATA INPUT AND ANALYSIS

    We input, review, code and control the consistence of the data. We secure their final validation along with the basic gel.

  • STATISTIC ANALYSIS

    Sample calculation, the statistic analysis plan (SAP), the randomization list and the statistic report are produced by the biostatistics service equipped with the SAS software.

  • REGULATORY FORMAT REPORT

    Reports are written in the regulatory format required by our clients or by the concerned countries’ competent authorities.

ADVICES AND ADDITIONAL DELIVERIES

  • TOXICOLOGY

    Pharmascan takes care of formulae reviews, safety reports, essential requirements’ compliance and certificates.

  • METHODOLOGY

    Experiment plans, medical expertise, choice of the studied population,  inclusion/exclusion criteria, scope definition and choice of evaluation criteria, study kinetic, type of sampling and choice of monitored biologic markers:

    Pharmascan accompanies you from A to Z!

  • REGULATORY AFFAIRS

    Our expertise allow us to interfere in:

    • The study’s legal framework.
    • Meeting obligations vis-à-vis regulatory bodies such as ethic committees / competent authorities in the country(ies) where the studies are done.
    • Helping create Investigator Brochures.
    • Meeting the Data Protection Act.
    • Meeting ISO 14155 / 10993 standards.
    • Having compliant authorized health claims files.
  • TECHNOLOGICAL WATCH AND BIBLIOGRAPHIC SEARCH

    Being present at numbers of scientific congress all year long, we secure a permanent technological watch.

    We closely follow technical and sales publications and analyze many specialized press reviews.

    For each of your problems, Pharmascan can therefore offer for your projects, innovative recommendations with a real added value.

  • SCIENTIFIC COMMUNICATIONS AND MARKETING

    With Pharmascan you have a complete offer. We guide you in writing articles, creating scientific posters, organizing conferences and trainings, etc.

    We also develop power points, animations, marketing clips, videos, etc.

You have a question, need information or a quote?

Pharmascan listens to you and offers you the most appropriate test solutions for your projects.

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