+++ news +++

updated September 2008

+++ ECRON and Manipal AcuNova (MAL) announced a definitive agreement to merge +++ The company name will be ECRON AcuNova. The new company will provide end-to-end services for phase I - IV clinical trials including project management, clinical data management (CDM), biostatistics, medical writing, central lab and bio-availability/bio equivalence (BA/BE) studies to pharma, biotech, device and diagnostic companies +++   Letter from President  Letter from Vice Chairman

+++ EU good practices on their way for implementation in the Ukraine +++ Ukraine’s association of pharmaceutical manufacturers (AFPU) works towards translation of all essential EU good practice standard documents into Ukrainian to be adopted as the national standard. The Ministry of Health now formed a new council for the development and introduction of good practices in Ukraine to work out a plan for the development and gradual enforcement of good practice standards by January 1st, 2009 +++

+++ Symfo has released a Russian version of its SymQuest eDiary. It recently announced that the total number of clinical sites where SymQuest was involved had reached 13,000 and that more than 30 million data points had been transferred by patients. It expects these figures to grow in 2007 +++

+++ Ukraine's parliament has passed a bill on amendments to the national law on medicines +++ It is focused on the harmonisation of national legislation with EU and World Trade Organization requirements +++

+++ BMG (Germany) presents report concerning the application of the GCP regulations +++ In October 2006, the Federal Ministry of Health presented a progress report to the Bundesrat (second chamber of the federal parliament) concerning the implementation and application of the GCP regulations. To begin with, the report states that Germany comes second after the United Kingdom with regard to the number of clinical trial applications submitted in Europe. And Germany even comes first compared to all other European member states if just the pivotal trials of the pharmaceutical industry are taken into consideration in the statistics +++

Only for German Sponsors
+++ Kernaussagen zur „Bedeutung nicht interventioneller Studien für die Bewertung der Wirksamkeit und der Sicherheit von Arzneimitteln“ aus der Reihe BfArM im Dialog, veranstaltet am 29. August 2006 +++
IMAGE VON ANWENDUNGSBEOBACHTUNGEN: Das Auseinanderklaffen von Anspruch und Wirklichkeit bringt das Instrument der AWB in Misskredit. Kritikern zufolge dienen AWBs fast ausschließlich Marketingzwecken und selten dem wissenschaftlichen Erkenntnisgewinn. Die AWB könne in der jetzigen Form nicht weiter bestehen.
GENEHMIGUNGSVERFAHREN: Das BfArM gibt auf Anfrage Scientific Advice für die Durchführung von AWBs. Kritiker fordern eine Verpflichtung zur Begutachtung durch das BfArM. Ein positives Ethik-Votum dürfte in Zukunft unabdingbare Vorraussetzung für die Durchführung von AWBs sein. Deshalb wäre es ggf. je nach AWB schon jetzt sinnvoll, ein freiwilliges Votum einzuholen (z.B. damit eine in Deutschland gestartete AWB in einem anderen EU-Land mit Votumspflicht nicht zurückgewiesen wird)
AUSSICHTEN: AWBs werden als gutes Instrument für künftige Kosten-Nutzen-Bewertungen angesehen. Der Begriff Non-Intervention stellt in diesem Zusammenhang eine Illusion dar. Dr. Armin Koch, leitender Statistiker des BfArM: Wenn eine AWB wie eine randomisierte klinische Studie ohne Randomisierung durchgeführt wird, sind seitens des Amtes die gewonnen Aussagen als valide zu betrachten. Wie bei anderen Studien auch ist erst das Ziel zu definieren und dann das geeignete Werkzeug, mit dem man dieses Ziel erreicht.
ECRON bietet:
Auf Ihre Bedürfnisse maßgeschneiderte Konzeption und Durchführung von AWBs und klinischen Studien
Diskussion Ihrer Projekte mit dem BfArM
Hohe Qualität auch bei AWBs  info@ecron.com

+++ Symfo has released the newest handheld eDiary +++ In order to better meet the needs of the customers, Symfo has recently developed SymPhone, a Java (J2ME) smartphone supporting Unicode and capable of recording patient data the same way as the SymQuest diary. SymPhone can be used to record either short or long questionnaires by study subjects in real-time, allowing for higher quality data – and improved patient compliance. Pictures can also be easily integrated, when necessary. SymPhone uses secure GSM (Global System Mobile) wireless technology for data transfer. In addition to SymPhone and SymQuest Symfo offers SymVoice, an Interactive Voice Response System (IVRS) using Voice XML technology which allows fast deployment and extreme flexibility and SymPro, a cost-effective solution for recording symptoms, medication intakes, and brief questionnaires +++

+++ Spanish medicines agency appoints new director +++ The ministry of health has appointed Professor Cristina Avendaño to take over from María del Val Díez Rodrigálvarez. Since 2003, Professor Avendaño has been a member of the scientific assessment committee of the government's R&D plan, Profarma, and part of the editorial team for a health service magazine +++

+++ Slovak institute for drug control to become agency +++ Slovakia's government is drafting an act that should transform the state institute for drug control, the SIDC, into the agency for human pharmacy (SAHP). The institute says the new act will improve the transparency of state administration of pharmaceutical policy and make it more patient-friendly, as well as give the agency new competence and more freedom to make decisions. In 2005, the SIDC's department of drug safety, a coordinating centre for pharmacovigilance and adverse drug reaction reports, began passing ADR reports obtained from local doctors to Eudravigilance, the EMEA ADR database and started up a similar national database. The total number of ADR reports received by the SIDC last year exceeded 40,000, with 129 passed to Eudravigilance. The institute assessed 97 clinical trial applications, authorised 99 (some carried over from the previous year) and refused one. It also conducted 12 GCP inspections +++

+++ Directive 2001/20/EC implemented successfully in Sweden +++ According to the MPA, the Swedish regulatory authority, the implementation of the new EU Clinical Trials Directive has proved successful. Only minor changes were required in the Swedish regulations, since MPA approval for clinical trials was already obligatory before, and clinical trials in Sweden have been conducted in accordance with Good Clinical Practice for many years, both for commercial and non-commercial trials. As a rule, investigational medicinal products should be made available free of charge by the sponsor; however, Swedish law allows for exemptions from this requirement, so non-commercial sponsors have not been deterred from performing clinical trials in Sweden. In 2003, one third of all clinical trial applications in Sweden were submitted by non-commercial sponsors/investigators +++

+++ The European Medicines Evaluation Agency (EMEA) has been renamed the European Medicines Agency. The acronym remains the EMEA +++ The Committee for Proprietary Medicinal Products (CPMP) is changing its name to the Committee for Medicinal Products for Human Use. The new acronym is the CHMP. The committee will henceforth have 25 members, one from each of the existing and new EU member states, rather than two from each member state as at present +++ The new Committee for Herbal Medicinal Products is named Herbal Medicinal Products Committee (HMPC) +++ The CHMP's veterinary equivalent, the Committee for Veterinary Medicinal Products, the CVMP, is changing its name, to the Committee for Medicinal Products for Veterinary Use, retaining its present acronym +++

+++ New clinical trials database for the EU +++ European regulators will now have access to details of all clinical trials of medicines being conducted in the EU, after the EudraCT database was launched by the European Medicines Agency (EMEA) to coincide with the entry into force of the clinical trials Directive (and EU enlargement) on May 1st, 2004. EudraCT will give national authorities a common set of information on Clinical Trials taking place in the EU, which the EMEA says will help supervise trials and protect people taking part in them. The system comprises a website that is available to clinical trials sponsors and a secure database that is only accessible by the competent authorities of the member states, the Commission and the EMEA. Sponsors of trials use the web-based tool to obtain a EudraCT number before applying for permission to conduct a trial; this number is the unique identifier of each trial. They then create and save database in xml format and print the completed application form, and submit this together with the dataset and other documents to the relevant national authorities. The member state agencies then enter the data into the secure database, and subsequently add information on their authorisation of the trial, the ethics committee opinion, amendments, the end of the trial and inspections. The EudraCT system was developed in collaboration with trial sponsors from both the pharmaceutical industry and academia, as well as representatives of the member states +++

+++ New rules for online application submission from BfArM +++ The German regulatory agency, BfArM, has tightened the rules regulating the online submission of marketing approval applications. First, specific file names have to be used, such as "QOS" for quality overall summary. The agency has listed these names (as well as the updated rules in general) under the news section on its website, but the companies can add a hyphen to these names and an internal name if they so will. Otherwise the rules of the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use will apply. Moreover, the e-mail address has been changed to: zulassung@amg-zulassung.de, and instead of sending separate files, companies are asked to compress them into a zip- or tar container, and attach this to the e-mail with one of the files identifying the product. Finally, companies have to add a seven-digit number which they can obtain by contacting the agency beforehand, in the subject headline of the e-mail. BfArM notes that this regulation is scheduled to be updated again on April 1st +++

+++ Participants in a recent project meeting +++

involving trial centres in Europe and overseas (including South Africa, Taiwan and Australia)

+++ ECRON successfully uses Oracle Clinical version 4.5 at servers in Frankfurt/Germany and New York/USA applying global dictionaries and harmonised procedures, this includes as well Remote Data Capture (RDC) +++ Successfully completed studies (4000 + patients documented) prove that using Oracle Clinical (since 2000) improves data management procedures with respect to quality and speed +++ Using Oracle Clinical as data management system and using SAS as statistical analysis and reporting system, ECRON offers state of the art technologies to our clients in Europe and North America, which exceeds their expectations +++

+++ New rules to improve Indian clinical data +++ The Indian government has outlined a framework for the setting up and functioning of ethics committees and put in place a checklist for informed consent documents as part of a major overhaul of the regulations governing clinical trials in India +++

ETHICS COMMITTEE: A committee should have a quorum of at least five members for each protocol being reviewed. The committee should appoint, from among its members, a chairperson and a secretary, while the other members should include a "mix" of medical/non-medical, scientific and non-scientific representatives and the lay public, to reflect different viewpoints. In addition, depending on the requirements of the area of research, specific patient groups may also be represented on the committee.

INFORMED CONSENT: A checklist for informed consent documents highlights certain essential elements which must be included such as the expected duration of participation, description of the procedures, including invasive procedures, to be followed, and a statement describing the extent to which confidentiality of records identifying the subject will be maintained and who will have access to these medical records.

PHASE LAG: The new draft regulations also remove the "phase lag", requirement under which all clinical trials in India must be one phase behind the global development stage of the drug in question. After early Phase I data generated outside India are submitted to the licensing authority, permission may be granted to conduct concurrent or repeat Phase I studies in India. Similarly, Phase II/III trials taking place concurrently with other global trials for that drug would be permitted in India after the new regulations take effect.

+++ Italy implements EU Pharmacovigilance Directive +++ The Italian government has published the decree (No 95/2003) implementing the provisions of the 2000 EU Directive on pharmacovigilance +++ The Italian decree sets out the obligations of the various players in terms of reporting ADRs.
Marketing authorisation holders and company heads of pharmacovigilance are subject to sanctions if they fail to meet their ADR reporting obligations +++ For companies, the decree sets these penalties at 30.000 - 180.000 Euro, plus 0,1 -1% of the value of sales of the product concerned +++ For heads of pharmacovigilance the fine is set at 20.000 - 120.000 Euro +++

+++ At present about 700 experts are eager to serve you within the ECRON group +++

+++ Recent FDA Audit at two German sites for drug trial (alcohol dependence) +++ only few minor findings +++ Inspectors spontaneously stated that the data collected were absolutely credible due to close to perfect standards +++

+++ The Croatian Ministry of Health and the Croatian Doctors' Assembly have drafted clinical guidelines for 12 diseases in order to standardise treatment of these conditions throughout the country +++ Guidelines, which are based on EC practice, are intended to remove discrepancies in the management of some of the most common ailments +++

+++ all senior monitors of ECRON who sat the ACRP exam passed it well above standard +++ certified CRAs guarantee that your projects are being handled with utmost diligence +++ the certification proves that our training methods are excellent +++ if you want to know more about how to integrate certified CRAs in your studies contact our headquarters +++