Drug Development Consulting

Pharma IT has an experienced team of Drug Development Consultants ready to assist you with services in all the phases from early phase clinical development until late phase; and well into the post-marketing phase.

We currently cover the following specialty areas with our own consultants

  • Chemistry, Manufacturing and Controls (CMC)
  • Clinical Trial & Operation
  • Scientific & Medical Writing
  • Clinical Data Management
  • Drug Safety & Pharmacovigilance

Where as the following areas are covered by partners and via our extensive freelance consultant database:

  • Biostatistics
  • Regulatory Affairs

If you need support don’t hesitate to contact us.

Meet the Drug Development Consulting team:

Data Management Consultant
Frank Andreasen

Senior Data Manager with more than 17 years of experience within the pharmaceutical industry.  Clinical Data Manager experience encompasses; CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, user acceptance test, system validation, standard procedures, laboratory data, data import/export, coding procedures, CDISC SDTM standards, risk-based monitoring and data management oversight.

Director of Clinical Trial & Operations, Clinical Trial & Operations Consultant
Maria Wriedt Jakobsen

Experienced Clinical Trial Manager and Project Manager with more than 10 years of experience in planning, running and managing all phases of international clinical trials. Experience with writing protocols, oversight plans, risk management plans including risk based monitoring, communication plans and executing investigator meetings, monitor meetings and internal company clinical trial meetings. Experience with setting up laboratories, eCRFs etc. and experience with vendor and stakeholder management.

GCP, ICH GCP E6 R2, GCP monitoring, Project Management, Change Management, Outsoucing of clinical trials, Observational studies, RA M8: Clinical Development and Documentation
Chemistry, Manufacuturing and Control (CMC) Consultant
Torben Elhauge

Holds more than 25 years’ experience from the Pharmaceutical industry within the CMC area

With an offspring in Analytical development, Torben has a broad experience within all parts of the CMC area from development over validation and registration to GMP release of products.

Torben is experienced in working with Impurities, Stability, Specifications, Release of Investigation Medicinal, CRO’s and Tech Tranfer. Torben have assessed registration files at the Danish Medicines Agency and have written the analytical part of the registration file for several products.

Torben holds a master’s degree in chemical engineering.

GMP
Pharmacovigilance Consultant, Quality & Compliance Consultant
Maria Skou Andersen

Cand.pharm with five years of pharmacovigilance experience including strong knowledge of MedDRA coding. Successful completion of EMA’s XEVMPD knowledge evaluation. Capable of providing guidance and training to new EVWEB users for them to comply with the reporting guidelines. Capable of creating and updating XEVMPD records. Experienced with databases such as Argus, Empirica and QlikView. Currently studying Master of Pharmacovigilance at the University of Hertfordshire, UK. EDMS system expert with advanced Veeva system administrator certification and experience with Veeva implementation. Experienced with compliance tasks such as system validation within the drug safety area.

Certified Veeva Vault Administrator, Veeva
Medical Writer Consultant
Kaushik Sengupta

Senior Medical Writing Consultant with over 8 years of experience from the pharmaceutical industry as a Senior/Expert Medical Writer. Has prepared numerous high-quality regulatory and research documents for leading global pharmaceutical companies. Typically, these documents have been based on Phase I–IV studies from most major therapeutic areas. Holds a Master in Dentistry from Canada and has pursued a PhD in epidemiology from Copenhagen University.

Pharmacovigilance Consultant
Mie Altermann Sørensen

Pharmacovigilance professional with 6 years of experience from the pharmaceutical industry. Experience from working in both headquarter and affiliate. Includes: Signal detection, literature monitoring, pharmacovigilance training, individual case safety report processing, including coding and narrative writing, scientific evaluation and reporting. Medical information activities; writing medical responses to health care professionals, direct costumer contact. Studying Master of Medicines Regulatory Affairs. 

Data Management Consultant
Jens Sørensen

Clinical Data Manager with pharmacy background and 18 years of experience from the pharmaceutical industry. Experience as both insourced and outsourced consultant with all aspects of clinical data management including; CRF/eCRF design, database design, data entry, data 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 and data management oversight.

Pharmacovigilance Consultant
Louise Søgaard Nielsen

10 years of experience as a pharmacovigilance professional. Experience with all aspects of pharmacovigilance including; ICSR case processing and reporting, Signal Detection, PSUR and DSUR writing and submission; Risk Management Plans and maintaining and building quality management systemst a larger pharmaceutical company in the Copenhagen area.

Data Management Consultant
Faiyaz Hussein

Is a Data Manager with 15 years of Clinical Research experience with respect to Project Management, Data management, eCRF and database designing, validation of IT systems, integration testing, reporting on varied EDC systems, electronic patient reported outcomes ePRO, edevices in diabetes care (Insulin pumps, CGM) and submission to Health Authorities with major pharmaceuticals.

21 CFR Part 11, GCP, Six Sigma Green, BASE SAS, Inform, Medidata Rave, Clintrial 4.4 EDC’s and OC/RDC
Pharmacovigilance Consultant
Kristine Kornøe

Experienced in clinical and postmarketing safety after working 6 years as a Drug Safety Advisor in a large danish HQ. Experience include: Signal Detection, PSUR/PBRER and DSUR writing and submission; Risk Management Plans; maintaining and building quality management systems; pharmacovigilance training, E2B reporting, ICSR case processing and reporting.

Data Management Consultant
Evangelos Kapris

Experienced Clinical Data Manager with experience within: CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk-based monitoring and data management oversight.

M.Sc. Data Mining
Director of Drug Development, Pharmacovigilance Consultant
Ea Marie Holst
+ 45 30 22 23 21

More than 13 years of experienced as a pharmacovigilance professional. Experience from both headquarters and affiliates with all aspects of pharmacovigilance including; Signal Detection, PSUR/PBRER and DSUR writing and submission; Risk Management Plans; maintaining and building quality management systems; pharmacovigilance training in the companies and outside, E2B reporting and testing, ICSR case processing and reporting. Experience with Medical Information and Promotional Material Review.