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LATE PHASE Services
Non Interventional Studies and Real World Evidence generation

Non Interventional

Post Authorization Safety & Efficacy Studies

Late Phase Expertise

Observational studies are studies in which subjects are observed within routine clinical practices. Different study designs are used with the objective:

  • to assess the association between a treatment (drug, Medical device, Medical procedure) or a health status with a particular event of interest (effectiveness, Safety, Patient Reported Outcomes)
  • to describe a population of patient (epidemiology), the use of a treatment in real life setting (Drug Utilization Study) or the occurrence of health status

These non-interventional studies have become critical for regulators to assess Drugs and Medical Device usage in Real World in addition to Clinical Trial findings.

As a provider of pharmaceutical, biotechnology and medical device industries, we offer services in the post-marketing areas and late phase studies as well as Patient Support Programs, and pharmacovigilance including risk management plans and risk minimization strategy.

Patient Registry

Following FDA definition, a Registry is an organized system for the collection, storage, retrieval, analysis, and dissemination of information on individual persons exposed to a specific medical intervention who have either a particular disease, a condition (e.g., a risk factor) that predisposes [them] to the occurrence of a health-related event, or prior exposure to substances (or circumstances known or suspected to cause adverse health events.

Post Authorisation Safety Studies (PASS)

Following EMA definition, PASS is any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures. Procedure for PASS Procedure is defined in Guideline on good pharmacovigilance practices (GVP) Module VIII.

Post Authorisation Efficacy Studies (PAES)

PAES is a study that aims to clarify the benefits of a medicine on the market including efficacy in everyday medical practice. PAES imposed as a condition to the MA is reflected in Annex II under section D “Obligation to conduct post-authorisation measures”.

Epidemiological Studies

Epidemiology is the study of health in populations to understand the causes and patterns of health and illness. The 3 main designs used in epidemiology are Cohort Study, Case Control Study and Cross-Sectional Study.

Patient Reported Outcomes: Quality of life, drug Compliance/adherence, Patient satisfaction

The FDA defines a patient-reported outcome (PRO) as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else”. Patient-reported outcomes typically include information about health-related quality of life (HRQOL), symptoms, function, satisfaction with care or symptoms, adherence to prescribed medications or other therapy, and perceived value of treatment. PRO data are used to inform and guide patient-centered care, clinical decision-making, and health policy decisions and are an important component in learning healthcare systems.

Pharmacoeconomic Studies

Health economic analyses can be classified according to the type of comparison of the costs and consequences (Cost-minimisation analysis, Cost-effectiveness analysis, Cost-utility analysis, Cost-benefit analysis). Depending on the type of analysis, the assessment of the outcome ranges from non-assessment through assessment in non-monetary, naturalistic units to monetary assessment. The choice of method of analysis depends on the research question.

Observational Studies

From an EU regulation perspective, a study qualifies as non-interventional and does not fall under the scope of the clinical trials directive 2001/20/EC, provided the following requirements are cumulatively fulfilled:

  • Medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorization
  • Assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study
  • No additional diagnostic or monitoring procedures are applied to the patients, and epidemiological methods are used for the analysis of collected data. Of note, interviews, questionnaires, and collection of blood samples may be performed as part of normal clinical practice

Local legislation in Europe can impact the process of submission to competent authorities and Ethics committees for NIS. Zeincro has a huge experience on local legislations on countries where it operates.

Survey and Market Research

Pharmaceutical market surveys deals with the collection, analysis, and interpretation of details and information relating to the medical/market environment of a given pharmaceutical product. The primary objective is to gain as realistic and objective as possible an impression of the medical environment/marketing opportunities of a given pharmaceutical product, thus enabling the identification of the chances and risks associated with its development potential as early on as possible. This can be performed using questionnaire sending to participants or organizing Focus groups in which a small group of participants gather to discuss a specified topic or an issue to generate data.

Non Interventional - Post Authorization Safety & Efficacy Studies

Late Phase Services

The services that ZEINCRO can provide in each clinical study include the following aspects:

Medical Writing

  • Preparation and writing of scientific documents such as protocol synopses and full protocols, patients’ informed consent and case report forms
  • Conduct of literature searches as appropriate for publication/document development
  • Development of study report and communication supports (abstract, article, poster)

Monitoring

  • Feasibility
  • Recruitment and selection of study sites
  • Organization & conduct of Investigators meetings
  • Files preparation and submission to Ethics & Regulatory Authorities
  • Set up and maintenance of study files
  • Contracts negotiations and submissions to Regional Financial Organizations and Universities
  • On-site management and Remote monitoring activities – Risk Based Monitoring Approach
  • Safety Reporting
  • Management of investigators payments and clinical grants

Project Management

  • Strategic study planning, identification/recruitment of investigational sites & patients
  • Project team management & support of all team members
  • Continuous communication with the sponsor
  • Ongoing tracking of the study status
  • Completion of the study according to the agreed budget and timelines

Data Management

  • Data base design
  • E CRF or Paper CRF
  • Queries Management
  • Medical coding using MedDRA or WHODrug
  • SAE reconciliation
  • Database Validation

Statistics

  • Sample size evaluation
  • Statistical analysis Plan development
  • Statistical analysis

Patient Support Services

  • Call Center Service
  • Field Force Health Care Professionals Network Training and Maintenance
  • Data Privacy insurance
  • Adverse Events and Product Complaints collection and reporting
  • Reports generation to Sponsors
  • Patient Follow Up/Reminder dosage/regimen services
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ABOUT US

ZEINCRO is a leading contract research organization covering more than 21 countries in Europe, with a special focus in the region of Central and South Eastern Europe (Albania, Austria, Bulgaria, Cyprus, Czech Republic, Germany, Estonia, FYROM, Greece, Hungary, Latvia, Lithuania, Malta, Moldova, the Netherlands, Poland, Romania, Slovakia, Switzerland, Turkey and Ukraine).

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CONTACT US

  • Email:  info@zeincro.com

ZEINCRO : member of

European CRO Federation (EUCROF)

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