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“The science of statistics in pharmaceutical development is a highly specialized field. Particularly Drug Product Development requires not only comprehensive statistical knowledge, but also out of the box thinking. Combining an academic mindset with industrial know-how, Arlenda definitely has the right skills. They have proven to be a valuable partner for us. Arlenda reliably helped us doing our complex statistics with great expertise and new tools greatly improving speed and quality.” Pol Adriaansen, Head of Formulation Development, Crucell

 

« As a pharmaceutical analytical development lab we need to have a method validation methodology, which is in accordance with regulatory documents and that uses a statistical evaluation approach relevant to these definitions. To apply validated and easy-to-use software using appropriate statistics, high level expertise in statistic and SAS application is required. Within this scope e-noval, developed by Arlenda was implemented at UCB.
As the e-noval software is a web-based application there are no specific hardware requirements which imply no extra installation costs. The manual is online available and can be consulted when logged into the program. The result reports generated by e-noval are ready to be imported into our documentation system. The use of the accuracy profile allows an unequivoque evaluation of the validity of the method. Regarding outsourcing of validation activities, the use of e-noval enables us to communicate predefined injection schemes in accordance with the validation protocol, which are easy understandable. Due to the straightforward excel data-input interface a rapid evaluation/check of the validation data is possible. Currently e-noval is used for both drug product and drug substance methods. In general we claim that the implementation of e-noval reduced the time necessary to validate a method: manipulations by 25%, calculations by 50% and reporting by 75%. »
 David Clicq, Scientist and Filip DeBoever, Associated Director, UCB Pharma S.A. - Braine-L'Alleud, Belgium

 

« For our laboratory, the enoval software is the answer to the main problem questioned by iso-17025 and iso-15189 requirements: how to establish uncertainty of measurement of chromatographic techniques used in Toxicology ? Our samples are often complex (blood, organs, urine, hair,...) and their analyses require quite long pre-treatment and fairly complicated chromatography, with consequences on validation protocols.
With the enoval software, typical analytical validations are done in three days (samples series can be long, until 35 samples by series), results are collected and encoded in Excell spreadsheet and they are next directly imported in enoval. Very complete validation reports are obtained in a few minutes and can be easily integrated in standard operating procedures. They allow us to answer to Belac (Belgian Accreditation) criteria in a completely professional way. » 
Nathalie Dubois, Service de Toxicologie Clinique, Médicolégale, de l'Environnement et en Entreprise (Prof. Dr. Corinne Charlier), CHU - Liège, Belgium

 

« Accuracy profile is an approach that has been developed to help to assess the performance of an analytical method and to validate this method. We have participated to the development of this approach and we use it regularly in our laboratories. Furthermore, this approach is now quoted in the French guideline NF V03-110. e-noval implements this accuracy profile method. » Michel Laurentie, head of Pharmacokinetic-Pharmacodynamic unit and responsible of statistical analysis platform for validation of analytical method and proficiency testing, Anses, laboratoire de Fougères

 

« Since 1997, we have been engaging with the accreditation process and the methods validation. The research we had carried out had led us to pick the error calculation model, but it turned out that the person in charge of the calculations was wasting time on spreadsheets. We discovered the Enoval software at the beginning of 2006. Complying with the requirements of the ISO-17025 standard, Enoval is easy to use and allows us to share the calculations job among the department staff. The validation reports are issued very quickly, without any verification calculation and tedious calculation control. Thanks to this time saving, the person who used to be in charge of the validation job is now working full-time on toxicological studies. From their first visit, the COFRAC auditors have accepted Enoval use and have approved of our choice. Several other forensic departments of the French gendarmerie forensic institute have been accredited while using methods validated through Enoval. In our opinion, Enoval software is a pre-analytical tool, compatible with accreditation and completely integrated in our daily work.» Olivier Roussel, Toxicology department, French gendarmerie forensic institute, Rosny-sous-Bois, France.