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Sourcing Inquiry Logo PSN - Pharmaceutical Service Network

PSN - Pharmaceutical Service Network

Regions
Worldwide
Countries
Spain, United States
Size
250-500
Specialty
Human Medicines
Service category
Clinical development and testing, clinical CRO
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Key services

Services

PSN is a committed provider of clinical research services for biotechs, pharmaceutical companies, and independent institutions. We have proven experience and expertise in assisting the drug and medical device development process. psn fits your specific needs by delivering tailored services; we offer flexible and fast solutions to your clinical development needs.

 

Monitoring Clinical Trials

 

psn offers a unique alternative for starting up and conducting clinical trials. The local monitors are coordinated by a single study manager located in your country, fully dedicated to your project, producing high-performance results in accordance with local regulations and ICH requirements.

Performance is ensured by their personal knowledge of the local Investigators, insight into optimal local strategies, medical culture and local language.

psn offers a wide range of services:

  • Feasibility studies
  • CRF design for easy completion by the Investigator
  • Administrative and regulatory steps
  • Pre-study, initiation, monitoring and close out visits
  • Site-specific support and telephone monitoring
  • Source data verification
  • Trial Master File Management
  • Query resolution
  • Investigational Product Accountability
  • Safety Monitoring

Project Management

 

psn has broad experience managing international projects. We use a customizable Clinical Trial Management System called TrialVista.

TrialVista is a fully customizable operational management tool that maximizes resources and improves the efficiency of clinical development.

These are also standard services that psnprovides:

  • Plan the study management
  • Study management identification and evaluation of clinical sites
  • Investigator recruitment and investigator meetings
  • Protocol conception in conjunction with statisticians and regulatory personnel
  • Real-time status reports
  • Investigator payment management
  • Complete trial management tracking
  • SAE/SUSAR/AE reporting system
  • Vendor management
  • Clinical supply and investigational product management

Data Management & Statistics

 

psn's main goal is to deliver quality databases on time and within budget. We understand that data analysis is a critical component to each study and its procedures and systems are compliant with ICH and GCP Guidelines, including FDA 21 CFR Part 11.

psn offers the following Data Management services adapted to sponsor´s requirements:

  • CRF design, review, printing and distribution
  • Generation of randomization list and coded envelopes (IVRS/IWRS)
  • Data management plan writing
  • Database design, testing and maintenance
  • Data entry (manual double or OCR-TELEform)
  • Upload of external data (e.g. laboratory, ECG, MRI, etc.)
  • Data validation plan writing
  • Consistency/plausibility checks programming
  • Data cleaning (including Data Queries management and DB Editing)
  • SAE Reconciliation (including management of discrepancies)
  • Data Management Report writing
  • Database transfer to Sponsor (SAS, SPSS, Oracle Clinical, Access, SQL)
  • Data coding (MedDRA, WHO Drug Dictionary, ATC, etc)

 Specific services related to Remote Data Capture / eCRF:

  • eCRF design
  • Project website preparation
  • Study database setup
  • Set-up of check controls
  • Set-up of the e-queries management
  • Set-up of On-line Automated reports
  • Definition, preparation and management of the users profiles/passwords
  • Technical system maintenance
  • Help-desk
  • Link with external database
  • Transfer of CRFs to Study sites

 psn offers the following Statistics services (SAS, SPSS):

  • Biostatistical consultancy on design and methodology
  • Development of statistical section for trial protocols
  • Adaptive design planning
  • Sample size calculation
  • Interim analyses
  • Statistical reports
  • Public health benefits studies
  • Biostatistical evaluations
  • Integrated statistical/clinical report

Clinical Trial Supply

 

psn is experienced in the handling of clinical trials supplies in all countries covered. In particular, psn has developed a special department which holds a GMP authorization issued by the Danish Medicines Agency for import, stock, randomization, labelling, repackaging and distribution of clinical trials supplies.

Our clinical trial supply department has developed a tracking system, which will accurately track all supplies received and dispatched. The system can even record each individual container dispensed to patients.

For long-term clinical trials with large numbers of subjects psn has developed a Drug Request System for re-supplies. This system is backed by a Drug Receipt Confirmation system via fax-in compliance with GCP for drug accountability. Periodic progress reports can be issued as required by the sponsor and can be made as detailed as necessary.

psn provides clinical supplies internationally and has experience distributing to EU, US, Canada, and Russia.

 

Medical Writing

 

psn can offer assistance with medical writing throughout Europe and the US. psn has qualified and experienced medical writers available to assist sponsors. All reports are prepared in strict accordance with US/EU/ICH guidelines and regulations.

A few examples include:

 

  •     Protocol design/review and amendments
  •     CRF design and preparation
  •     Clinical study reports
  •     Statistical reports
  •     Integrated summaries of safety and efficacy
  •     Patient informed consent
  •     Patient diaries
  •     Key opinion leader reports
  •     Investigator brochures
  •     Medical texts for package leaflets
  •     Scientific articles

Documents may be prepared in multitude of languages (Danish, Dutch, English, French, German, Hungarian, Italian, Norwegian, Polish, Russian, Spanish, Swedish, Romanian, etc).

 

Regulatory Affairs

 

psn offers a wide range of services in connection with registration of human and veterinary pharmaceuticals, medical devices and biotech products from a full registration package or customized deliverable to translation of a simple text into local languages.

Local presence and experience give psn a clear andvantage in assisting its clients with their regulatory needs. Submission activities to Regulatory Authorities (FDA, EMA, Local RAs) and Independent Ethics Committees are completed quickly and efficiently.

More specifically psn offers services within the following areas:

  • Development of complete registration applications
  • Submission of clinical trial protocols for regulatory authorities/independent ethics committees approval and follow-up
  • Modifications, amendments and updating of existing registration files
  • CTD for marketing authorization applications
  • Production of expert reports within the areas of pharmacy, chemistry, toxicology and clinical data
  • Translation of technical text and conduct of literature search
  • Production or evaluation of patient information sheets, package labels and summary of product characteristics
  • Special assignments

QA/QC/Auditing

 

Quality Assurance (QA) and Quality Control (QC) systems and procedures must be implemented by every pharmaceutical company to ensure that the ICH GCP guidelines and applicable regulatory requirements are adhered to during all the stages of a study.

psn has significant experience auditing vendors, partners and clients. psn's QA personnel can assist sponsors and investigators in improving the quality of study conduct and data collection through a range of audit services.

  • In-house data audit: Comprehensive review of key documents in the Trial Master File according to ICH GCP and agreed SOPs.
  • On-site audit: Audits of pivotal or supportive studies involving single or multiple investigator sites.
  • Biometrics audit: Review of a specific rate of randomised tables and graphs on all key variables, control of the procedures for data management, query production and handling, data base alterations, statistical calculations etc.
  • Clinical Report Audit: Audit of clinical reports against agreed SOPs and ICH GCP requirements.

Training & Education

 

psn can provide training for health authority organizations, pharmaceutical industry or medical devices industry conducted on a broad range of languages.

psn organizes international and national courses, workshops and seminars in several areas:

  • Advanced clinical trials management
  • Data management and medical statistics
  • Clinical trials on pharmaceutical compounds and medical devices
  • Final reports in clinical research
  • Audits on clinical trials, in-house and/or on-site
  • Fraud prevention in clinical research
  • Quality control and quality assurance in clinical research
  • Good Clinical Practice (GCP)
  • Pharmaceutical Good Manufacturing Practices in control and research laboratories
  • Method validation, the foundation of Good Laboratory Practice

The program of tailor-made workshops will be discussed and planned in detail with the client to be sure that the most effective result will be achieved.

 

Clinical Staff Outsourcing

 

Clinical staff outsourcing is very convenient for pharmaceutical and biotech companies as they apply economies of scale and risk sharing. Outsourcing can help to accommodate peak loads in your company.

psn provides qualified staff covering a full range of positions (Project Managers, Clinical Research Associates, Clinical Trial Assistants, Data Managers, etc). The staff is trained on ICH-GCP and has great experience on the pharmaceutical industry. Their CVs are available upon request.

 

PASS/PAES

 

Controlled clinical trials are the accepted gold standard for the assessment of therapeutic efficacy and are a requirement for the approval of new drugs by regulatory agencies.

Various limitations of Phase III studies (e.g. highly selected subject(s), limited subject(s) numbers etc.) make it mandatory to perform additional research following marketing approval of the drug. Possible aims of PASS and PAES (Post Authorization Safety / Efficiacy Studies) are to gain information about drug utilisation, to identify the rare adverse drug reactions (ADRs) and specific subject groups at risk of ADRs under normal every-day practice.

These studies are mainly scientific observational studies, prospective in design and comprise all characteristics of a one- or two-armed cohort-study. In addition the decision regarding choice and execution of the therapy is left completely to the discretion of the individual physician. If conducted according to actual guidelines, these can be regarded as scientifically valid research instruments.

psn offers a comprehensive service portfolio for PASS/PAES such as:

  • Planning and designing (incl. printing) of all necessary documents
  • Placement of the study at GP or clinic sites
  • Tracking of information flow
  • Organization and handling of investigator payments
  • Data management including AE-checking/reporting
  • Statistical analysis and medical writing

Over the last 20 years, psn has performed many PASS/PAES in various therapeutic areas.

 

Scientific & Drug Development Counseling

 

psn provides a professional consulting service by senior executive experts from the pharma and biotech industries. For many years, psn has maintained agreements with a comprehensive panel of well–recognized experts that work cross-functionally on several disciplines and therapeutic areas:

  • Drug development programs
  • Medical assessments and information
  • Evaluation of in-licensing and acquisition opportunities
  • Clinical development assessments and plans
  • Pre-clinical development assessments and plans
  • Regulatory strategies, procedures, assessments and plans
  • Pharmaceutical development and quality both small molecules and protein

Share with us your challenges and we will study the alternative options!

 

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