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Data management and bio-statistical evaluation

Data management and biostatistics are carried out according to the requirements
of FDA 21CFR Part11 and ICH E3, E6, E9.

The main activities covered:

  • Sample size determination
  • Writing the data management & statistical part of a study protocol,
  • Randomization procedures & generation of randomization envelops
  • Designing and preparing the CRFs
  • Preparing and validating the data entry system corresponding to the study protocol (Using ORACLE® database)
  • Writing the Statistical Analysis Plan (SAP)
  • Writing the Data Cleaning Plan (DCP)
  • Single or Double data entry with QC for data entry
  • MedDRA coding under medical control
  • Handling the Data Clarification Forms (DCF) or Data Query Forms (DQF)
  • Database closing
  • Statistical analyses according to SAP using SAS® software
  • Preparing the tabulated forms
  • Writing the statistical report according to ICH E3 (Structure and Content of Clinical Study Reports)
  • QA of the above activity according to ICH E6 (Guideline for Good Clinical Practice)

Developing Quality Assurance systems

AdWare Research Ltd deals not only with establishing but also with developing, preparing, educating and also maintaining the main quality assurance systems (ISO, GCP, GLP).

Independent audit services

As an independent auditor, AdWare Research Ltd conducts both trial-specific audits that cover all phases of the clinical trials, and systemic audits according to the Good Clinical Practice (GCP) or the Good Laboratory Practice (GLP) guidelines.

Organizing and monitor clinical studies

AdWare Research Ltd organizes pharmacological, toxicological and related preclinical studies to prove their safety and efficacy during pharmaceutical research. The investigations are based on the requirements of OECD, UCH and FDA and, if necessary, the places also fulfil the GLP prescripts.

Software / hardware validation
Food technology: R&D related technical troubleshooting services
  • Frozen foods, all aspects of manufacturing technology and product and process control
  • Heat preserved foods: application of Good Manufacturing Practices,
    process validation and temperature distribution studies.
  • Chilled foods: Good Manufacturing Practices for safety in the production and distribution of chilled foods;
    applications of Modified Atmosphere Packaging
  • Factory hygiene: cleaning and sanitation programmes, hygienic design, specification and monitoring.
  • Factory design.
  • Foreign bodies: advice in the avoidance, elimination and identification of foreign bodies;
    access to the extensive library of glass spectra at Campden BRI (UK).
  • Troubleshooting: investigation into problems of manufacture and distribution.
  • Primary production: Good Agricultural Practice; HACCP approach.
  • Flour milling, baking and cereal processing, with access to extensive pilot processing facilities (UK)
  • Microbiological advice relating to product safety and spoilage; factory design and operation;
    microbiological risk profiling.
  • Waste management
  • Cost reduction techniques

Food safety and quality management

Food safety and quality management verification, auditing and training, including HACCP, GMP and ISO 9000 supplier assurance schemes, Good Agriculture Practice. Factory inspection and audit against standards such BRC, IFS, ISO 22 000 or national sector specific GHP codes prepared under the leadership of Campden BRI Hungary Ltd. Technical advice for development of assured/labelled systems for plant and animal food chains and for traceability systems throughout the whole food chain. Advice, audit and quality monitoring services for supplier assurance systems.