Drug safety, Data Management and Medical Writing

 

Safety and Pharmacovigilance

Pharma IT has an experienced team ready to assist you within all aspect of pharmacovigilance. Whether you need urgent help during maternity cover, illness ect, or looking for more permanent outsourcing solutions as an entire process such as case handling, aggregrate report writing etc. or assistance during implementation of a new solution in your team.” 

Local safety representative

If your local Danish safety representative is absent, or you have a particularly busy period, our consultants are all experienced with the Danish pharmacovigilance legislation, and with safety training of sales staff, writing local SOPs, doing reconciliations and other tasks normally handled by your Danish safety representative. Please contact us if you have a shorter or longer term need for assistance.

QPPV services - EU Qualified Person for Pharmacovigilance

Due to medical expertise as well as numerous years of pharmacovigilance experience, our Danish-based consultants can act as EU-QPPV for your small pharmaceutical company and offer assistance in setting up the necessary procedures to support this role.

Assessment of Individual case safety report (ICSR)

The team is trained in data entry in the major used safety databases, and our consultants can handle every step from book-in, through data entry, quality control, safety review, medical review and distribution/reporting to authorities and partners.

Risk Management Plans (RMPs) and aggregated reports

With the release of the EU GVP Module V in March 2017, pharmaceutical companies need to adapt to a new standard of reporting. Our consultants are experienced in the old and the new format and can help you transfer into the new format; and additionally we are ready to help you with the content as well due to our experience across many different therapeutic areas. We are all very experienced writing other aggregated reports such as PSUR, DSUR, ACO and perform the benefit/risk assessment necessary for concluding on the safety of your product. 

Pharmacovigilance System Master File (PSMF)

Our consultants are very experienced in maintaining and building the PSMF for small to large size pharmaceutical companies. Often the demands of the PSMF needs to be reviewed and complied with before the first marketing authorization is granted in the EU, so please contact us, if you need strategic advice on how to set-up your system most efficiently and compliant. In addition to the business consulting, Pharma IT is also able to assist you with an electronic solution to tailor and implement to maintain the PSMF

Team & Contact

Please see our team here

If you want to learn more about our services please contact Director of Pharmacovigilance, Ea Marie Holst at eah@pharmait.dk / + 45 3022 2321

Pharma IT can assist with all aspects of clinical data management including;

  • eCRF and database design,
  • Data entry and validation
  • Query handling
  • Protocol deviations
  • SAE reconciliation
  • Quality control
  • Data import/export
  • SAS and SQL programming
  • Data migration
  • CDISC SDTM standards
  • MedDRA/WHODrug coding
  • Risk based monitoring
  • Data management oversight

Pharma IT embodies scientific and medical writing excellence

Pharma IT provides expert medical writing services in all key therapeutic areas. Our highly qualified professionals possess consummate medical writing expertise backed by years of experience in preparing clinical, regulatory, pharmacovigilance, and medical marketing documents for the world’s top pharmaceutical companies.

 

Our suite of medical writing services include

Regulatory and research documents

  • Study protocols
  • Informed Consent Documents
  • Case Report Forms
  • Statistical Analysis Plans
  • Study reports
  • Investigator’s Brochures
  • Summary of Product Characteristics/Prescribing Information
  • Clinical Summaries and Overviews (Common Technical Document Modules 2.5 and 2.7)
  • Subject Narratives
  • Developmental and Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports
  • Risk Management Plans

 Scientific publications and presentations

  • Journal articles (original research articles, narrative reviews, systematic reviews/meta‐analyses)
  • Congress presentations (abstracts, slide kits, posters, e-communications)
  • Publication planning support

Disease and drug-related educational and promotional literature

 

We possess expertise in reporting various types of research, including interventional studies, observational designs, pharmacokinetic/pharmacodynamic modeling and simulations, health economic assessments, and real-world evidence studies.

At Pharma IT, you can expect a high level of scientific rigor and consistent delivery of high-quality guideline-compliant documents to support your clinical development and lifecycle management programs.

 

Team & Contact

If you want to learn more about our services, please contact Ea Marie Holst at eah@pharmait.dk / +45 3022 2321.