May 2012
News Release: ICRC-Weyer Enhance Medical Data Management Services
Berlin, 8 May 2012: ICRC-Weyer has enhanced its expert medical data management services in order to strengthen its position as a leading provider of data management services in the market. The services are being delivered by knowledgeable medical staff who are responsible for manual medical data validation, medical coding, planning and organisation of ICRC-Weyer’s specialist medical review services.
ICRC-Weyer has a broad network of medical experts that specialise in various fields. Together with the supervision from the medical data management services team and their purpose-built tools and custom procedures, the company is able to provide services across a vast range of therapeutic areas.
Medical data management works closely with other departments at ICRC-Weyer, including pharmacovigilance and clinical data management.
April 2012
News Release: ICRC-Weyer Launch New Social Media Pages
Berlin, 19 April 2012: ICRC-Weyer GmbH has announced that the company has launched its corporate pages on the social networks Facebook and Google Plus in order to extend its presence in the global clinical research community. The company has been maintaining an active presence on business oriented networks such as LinkedIn and Xing and has now extended its social media activities to a wider audience.
ICRC-Weyer has been involved in several academic projects in order to pass on expertise in the field of clinical research and share its own experiences with the next generation of clinical research professionals. Key staff members hold various teaching positions at well-known universities where they give lectures and provide assistance and supervision to both undergraduates and postgraduate research students. “This is only a part of what we are planning to do on the social networks” says Mrs. Ahrens. “At ICRC-Weyer, we interact with special interest groups and communities in various areas, such as nutrition & functional foods, advanced therapies, CDISC submission standards for data management and biostatistics as well as expert medical review and pharmacokinetics. The social networks, in collaboration with our own website and blogs, provide excellent opportunities to connect with an engaged audience and to share relevant and interesting content online.”
For the management of their social media presence and their Internet marketing activities, ICRC-Weyer GmbH has chosen the services of Quadratek Connect Ltd., a UK-based provider of social media monitoring solutions for the life sciences industry.
Visit ICRC-Weyer’s social profiles
News Release: ICRC-Weyer To Adjust Services Portfolio In Light Of New European Health Claim Regulations
Berlin, 4 April 2012: ICRC-Weyer GmbH has announced an adjustment of their services portfolio which will enable manufacturers of dietary supplements and functional foods to benefit from the German-based CRO’s expertise and resources by conducting clinical trials for their products. The announcement was made following a decision by the European Parliamentary Committee on Environment, Public Health and Food Safety (ENVI) to pass a list of 222 health claims for dietary food supplements after officially being approved in a vote by the European Parliament.
Experts have been speculating as to what impact this will have on the industry, since all these claims will have to disappear from product labels after a transition period of 6 months. While products with ingredients that are well-known to the consumer may survive without health claims (such as probiotic yoghurts), innovative products with less known ingredients may vanish from the European market as it will become impossible for many manufacturers to prove health benefits through costly research and development.
“The outcome of this process will most likely mean the market for dietary supplements and functional foods in Europe being shaken to its core.” says Dr. Hardewig. “Only a few products will prevail and the big challenge for manufacturing companies will be to demonstrate the health effects of their products by conducting clinical trials.”
Since EFSA has published several guidelines on clinical data for many indications, such as weight management, healthy blood glucose levels and immune health, the requirements are now more clearly defined. This creates opportunities for European contract research organizations (CRO), but only few have the relevant expertise and actually provide services for both pharmaceutical and health claim studies.
Being one of these CROs, ICRC-Weyer GmbH is able to conduct trials which are tailor-made for dietary supplements and the intended claims. The delivery of clinically proven data by ICRC-Weyer GmbH on these claims will drastically improve chances for a product to obtain approval by EFSA and will enable dietary supplements providers to offer products in Europe, which will legally carry truthful and non-misleading health claims.
March 2012
Effective as of March 01, Johann Daniel Weyer, previously the company’s Authorised Representative (Prokurist), has joined the team of Managing Directors. He will take over the management of ICRC-Weyer together with Simone Ahrens and Prof. Dr. Weyer.
Deborah Denkert (Head of Data Management) and Stefanie Kupke (Medical Writer) attended at the AGAH Annual Meeting 2012 in Leipzig, where ICRC-Weyer also shared a booth with MPS-Hamburg. For further information please click here
Simone Ahrens attended the DGPharMed Jahreskongress 2012 in Cologne.
February 2012
Artjom Merjasch joined the ICRC-Weyer team as Medical Writer. He finished his BSc in Clinical Research and has several years of experience in the clinical research industry.
January 2012
Simone Ahrens and Iris Hardewig attended at the 13th Euroforum Annual Conference on nutrition. ICRC-Weyer shared a booth with our long time cooperation partner MPS-Hamburg. For more information please click here
December 2011
Please note that our office will be closed over the Christmas period. We will close on Saturday, 24th December 2011 and we will re-open on Monday, 2nd January 2012.
If you require assistance over this period, please send us an email to: info@icrc-weyer.comIn case of emergency, please contact us via the following mobile phone number: +49 172 94 37 735
ICRC-Weyer and its entire staff wish you a Merry Christmas and Happy New Year!
October 2011
Dr. Iris Hardewig will participate as speaker on EFSA requirements for health claim substantiation at the UBM Conference Clinical Trials in F&B held in London, 4th October 2011.
ICRC-Weyer will attend the Evolution Summit 2011 in Montreux, Switzerland, from 17th to 19th October 2011.
September 2011
As a registered member and constantly present attendant in the German CDISC User Group Meetings, ICRC-Weyer Data Management team is attending the 12th meeting on 22ndSeptember 2011, in Berlin, Germany. Main theme is ‘‘Trial Design Domains from protocol to analysis’’. However, other hot topics are presented e.g.: Standards for Data and Metadata in medical research, CDER Data Standards Common Issues Document, and others.
May 2011
ICRC-Weyer has organized a one day training workshop, arranged by a certified audit agency, for all its employees in May. The workshop was focused on compliance to GCP guidelines, in addition to briefing about German data protection law. Afterwards, all participants took part in the company’s yearly summer party. ICRC-Weyer’s employees are always keen to attend these social event as it is always a chance to strengthen the relations even across various departments.
April 2011
To enhance and update the expertise in our comprehensive CDISC services, ICRC-Weyer participated in the CDISC European Interchange Meeting in April 2011 in Brussels. Experts and interested specialists from all over the world came together to promote the Clinical Data Standards and to share knowledge. While extending the valuable network within the CDISC family, team members of ICRC-Weyer appreciated to attend workshops in the fields of CDASH and ADaM Implementation as well as Legacy Data Conversation. We thank the organizer, all instructors and participants for a successful event and advancing discussions.
March 2011
On its course for compliance with CDISC standards, ICRC-Weyer announces proudly that it now offers its clients eCTD CRF annotation, as well as the Case Report Tabulation Data Definition (define.xml) which includes the specification for the data definitions for datasets provided using the CDISC Study Data Tabulation Model (SDTM) in addition to its Checks and QC (e.g. hyperlinking). This aims to largely automate creation of reporting and analysis datasets, to substantially shorten timelines, and to greatly simplify data transfer between ICRC-Weyer and its clients.
January 2011
ICRC-Weyer is capable of offering monitoring services of large global clinical trial projects in addition to eCTD creation, preparation and submission through Creative Clinical Research (CCR) which represents a novel business model. CCR facilitates streamlining the workflow between ICRC-Weyer and Pharma Focus Ltd (PFC) as well as any other future CCRs team partners. CCR possesses special experience in the field of parenteral nutrition and global conduction of clinical trials.
December 2010
As of 1st December 2010 Mrs Simone Ahrens was nominated as the 2nd managing Director . Mr Daniel Weyer, Medical Data Manager, was appointed as an authorized representative of ICRC-Weyer effective from the same date.
August 2010
We are pleased to announce that ICRC-Weyer has been converted to Limited-Liability Company (GmbH). This transformation reflects our company’s growth and diversification. Prof. Dr. Weyer has taken over the management of the company.&nb
June 2010
We are glad to inform you, that ICRC-Weyer has moved successfully to its new office - Bölschestraße 2.
