Regulatory

We support the development of clinical studies (phases I-IV), including the conceptualization process and the preparation of documentation to be submitted to bioethics committees and regulatory agencies in Poland (The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products  [URPLWMiPB]) and elsewhere (European Medicines Agency [EMA], Food and Drug Administration [FDA]).
We are experienced in different types of studies, including observational studies, patient registries, and patient-reported outcomes.

STUDY DESIGN

PMW works with phase I-IV clinical studies and offers consultancy for all stages of study design, including the engagement
of investigators and experts, input from biostatisticians and the preparation of  effective study protocols.
Our scientific and industry experience results in a shortened planning phase, a successful submission to authorities
and an efficiently-designed study with the optimal number of patients.

DOCUMENTATION OF CLINICAL TRIALS

PMW prepares, edits and translates:

  • study concept sheets
  • study protocols
  • investigator brochures (IBs)
  • case report forms (CRFs) and electronic case report forms (eCRFs)
  • patient informed consent forms (ICFs)
  • EMA scientific advice documents
  • investigational medicinal product dossiers (IMPDs)
  • applications to competent authorities
  • narratives
  • statistical analysis plans (SAPs)
  • statistical reports
  • periodic safety update reports (PSURs)
  • development safety update reports (DSURs)
  • interim analysis reports
  • clinical study reports (CSRs)
  • clinical study registrations at clinicaltrials.gov, EudraCT, and the EU Clinical Trials Register


Following the EMA’s initiative (as of October 20, 2016) to grant open access to clinical reports for new medicines authorised
for human use in the European Union (EU), PMW prepares, in accordance with the EMA guidelines, the redacted CSR
to be published on the EMA website.

OBSERVATIONAL STUDIES, REGISTRIES

PMW provides simple solutions for maintaining complex patient registries and conducting observational studies, post-marketing studies (PMSs), and post-authorisation safety studies (PASSs), in accordance with GCP guidelines, EMA requirements and standard operating procedures (SOPs). Moreover, the interactive solutions offered by PMW enable close co-operation between investigators and sponsors,
and provide patient management tools that facilitate the day-to-day clinical care of patients.

PATIENT REPORTED OUTCOMES

PMW translates and validates patient-reported outcome (PRO) measures, including quality of life (QoL) measures, from the original language to the target one, mainly from English into Polish. The Polish versions of QoL questionnaires are prepared using double translation (forward and backward), according to the guidelines of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)¹. Alternatively, PMW uses dual translation panels². PMW also creates original PRO forms and offers validation of newly devised ones.

PMW provides patient feedback questionnaires for:

  • QoL
  • treatment and health care satisfaction
  • symptom and complaint assessment
  • personal, professional, and social functioning
  • general health


The PRO measures are used in both traditional and electronic formats in multicentre clinical trials (with centres using different operational languages), observational studies, patient registries, and day-to-day medical practice. At the same time, PMW advises on the selection of appropriate measures for a planned clinical study or supervises the process of creating a new form.

  1. Wild D, Grove A, Martin M, et al. ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health 2005;8:94-104. doi: 10.1111/j.1524-4733.2005.04054.x
  2. Swaine-Verdier A, Doward LC, Hagell P, et al. Adapting quality of life instruments. Value Health 2004;7 Suppl 1:S27-30. doi: 10.1111/j.1524-4733.2004.7s107.x