S2 ScienceSolutions

02/08/2018

31/12/2016

Patient registries may be an important source for “real life evidence” e.g. with regard to chronic and/or rare diseases or in the collection of drug utilization data. However they have be criticized on several levels including the concerning the standardization in data collection and potential competition for registered patients across registries which could create a fractured set of patient data.
PARENT (Patient Registries Initiative) is co-funded joint action by the European Commission and some member states. The overall objective is to support the EU-Member States in developing comparable and interoperable patient registries in clinical fields of identified importance thus enabling the use of secondary data for public health and research purposes in cross-organizational and cross-border setting.
The PARENT framework consists of:
__A knowledge management platform providing documents including guidelines, state-of-the-art reviews, best practices
__IT tools and models repository including software tools and links to external tolls and services relevant for patient registry implementers and holders.
__A Registry of Registries providing structured search across a number of EU Patient Registries.
The PARENT website might be a valuable source for initiators of registries as well as for marketing authorization holders seeking for existing data (e.g. within risk management planning or implementation).
Read more: http://patientregistries.eu/web/guest/parent

25/10/2016

The Topic Today is: Health Claims/PASSCLAIM
Union rules on nutrition and health claims have been established by Regulation (EC) No 1924/2006. The Regulation started to apply on 1 July 2007. This regulation is the legal framework used by food business operators when they want to highlight the particular beneficial effects of their products - in relation to health and nutrition - on the product label or in its advertising.
The rules of the Regulation apply to nutrition claims (such as "low fat", "high fibre") and to health claims (such as "Vitamin D is needed for the normal growth and development of bone in children").
The objective of those rules is to ensure that any claim made on a food’s labelling, presentation or advertising in the European Union is clear, accurate and based on scientific evidence. Food bearing claims that could mislead consumers are prohibited on the EU market.
The European Commission supported a concerted action project, "Process for the Assessment of Scientific Support for Claims on Foods" (PASSCLAIM). This project reviewed the scientific state of the art in diet and health areas regarded most likely for health claims. The main purpose of the PASSCLAIM project was to define a set of generally applicable criteria for the scientific substantiation of health claims. These criteria were considered to be a scientifically robust tool for evaluating the quality of the data submitted in support of health claims on foods. PASSCLAIM is useful in assisting applicants for a health claim to prepare their supporting dossiers as well as in aiding agencies responsible for evaluating the scientific evidence for the claim.
Read more: http://jn.nutrition.org/content/138/6/1210S.long

19/10/2016

The Topic of Today: Food Studies:
Beyond adequate health care the choice of an appropriate diet is of major impact on public health and constitutes a critical element in health protection. In light of this fact the informed decision of consumers based on a comprehensive nutrition labelling is essential – this applies in particular to food supplements and dietary or fortified foods.
To ensure a high level of consumer protection food business operators are obliged to issue solely well-sounded and scientifically proven nutrition and health claims which receive regulatory approval for the use in the European Community by a thorough scientific assessment.
With regard to this fact we offer long-standing experience in the conduct of high-level scientific studies in the food sector.

For further information visit us on:
http://www.s2sciencesolutions.com/en/

12/10/2016

The Topic of Today: Advantages of Outsourcing:
At comparable prices internal staff provides clear advantages: internal staff usually has a better understanding of company strategies, cultures and politics with a higher degree of loyalty. Moreover it has to be taken into account that outsourcing vendors ultimately work for different shareholders and must/will place their parochial interests first. However, when properly utilized and managed contractors may offer unique benefits:
Combining the volumes of multiple clients, vendors can achieve economies of scale reducing overall costs. This is not limited to physical processes but can include precious assets such as relationships and people.
Outsourcing may be used to minimize fluctuations in headcount resulting from peaks and valleys in demand. Particularly in case of occasional high peak loads contractors will save money even despite of higher costs per hour.
Well-managed outsourcing may also be a driver of company development either by “off-loading” less interesting activities leaving staff free to concentrate on innovative working areas or by bringing in fresh ideas and additional unbiased expertise by contractors staff.

Read more:
http://www.sourcingmag.com/4-advantages-to-outsourcing/

03/10/2016

A survey involving a representative sample of biotechnology companies evaluated issues and challenges around the impact of the Medical Affairs function: although recognized as a valuable partner of Marketing several key areas for potential organizational improvement were identified, all underscored by a need to find a balance between the role of Medical Affairs as information source and the need to appropriately support commercial interests. Possible solutions included a clear definition of Medical Affairs roles and responsibilities, an intensified alignment and early involvement in brand development as well as the application of best practice responses to the regulatory environment without over-compensation in company behaviors. Moreover the development of clear communication processes between medical and marketing functions and the definition of value metrics to demonstrate accountability for Medical Affairs activities was pointed out as critical factors to overcome current limitations in the utilization of Medical Affairs services.Off note, nearly two-thirds of the Marketing directors taking part in the survey acknowledged that Medical Affairs was understaffed. As the responsibilities of medical affairs departments increase outsourcing of activities does too. Survey results reveal that 83% of respondents from US medical affairs groups outsource some part of their budget corresponding to a 17% increase from 2008 to 2010. The two most commonly outsourced activities were medical information (at average 60% of activities budget) and medical education (at average 35% of activities budget). Smaller medical affairs groups choose to outsource 100% of certain activities e.g. medical publications work and medical information activities as the benefits outweighed the cost for hiring additional employees to handle activities internally while offering the possibility to get access to additional (maybe rare) expertise.
Read more:
http://www.campbellalliance.com/articles/Campbell_Alliance_Optimizing_the_Impact_of_the_Medical_Affairs_Function.pdf
http://www.cuttingedgeinfo.com/2011/outsourcing-of-medical-affairs-activities/

26/09/2016

The increasingly diverse range of medicinal products and medical devices requires the provision of high-quality information for decision makers in research and prescribing.
In the light of these facts the activities of medical-scientific and advisory functions such as “medical advisors” or “medical scientific liaison managers” become a vitally important factor for business success and turn into strategic positions.
Apart from professional competence, experience and personal networking skills a profound understanding for the linkage between scientific contents and its practical implications with regard to the mindset and the needs of various stakeholder groups is a major requirement.
S2 ScienceSolutions offers a variety of medical-scientific services as well as personnel secondment of medical advisors/medical scientific liaison managers.
For further information visit us on: http://www.s2sciencesolutions.com/en/

S2 ScienceSolutions offers services for clinical studies, vigilance, medical-scientific expertise and quality assurance

19/09/2016

Wir brauchen dringend Verstärkung in unserem Team und suchen CTAs und CRAs. Bei Interesse schicken Sie bitte Ihren CV an:
ks@s2sciencesolutions.com

18/09/2016

Patient registries may be an important source for “real life evidence” e.g. with regard to chronic and/or rare diseases or in the collection of drug utilization data. However they have be criticized on several levels including the concerning the standardization in data collection and potential competition for registered patients across registries which could create a fractured set of patient data.
PARENT (Patient Registries Initiative) is co-funded joint action by the European Commission and some member states. The overall objective is to support the EU-Member States in developing comparable and interoperable patient registries in clinical fields of identified importance thus enabling the use of secondary data for public health and research purposes in cross-organizational and cross-border setting.
The PARENT framework consists of:
__A knowledge management platform providing documents including guidelines, state-of-the-art reviews, best practices
__IT tools and models repository including software tools and links to external tolls and services relevant for patient registry implementers and holders.
__A Registry of Registries providing structured search across a number of EU Patient Registries.

The PARENT website might be a valuable source for initiators of registries as well as for marketing authorization holders seeking for existing data (e.g. within risk management planning or implementation).

Read more: http://patientregistries.eu/web/guest/parent

08/09/2016

Pharmaceutical companies may obtain scientific advice to help with the design of clinical trials for the generation of robust data for a benefit-risk assessment from the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA). In a 12-month pilot project starting in Q3 2015 the EMA extended this service to post-authorisation safety studies (PASS).
The service is focused on the evaluation of protocols for non-imposed PASS (category III), whereas imposed PASS still undergo a routine assessment by the PRAC or the competent authority concerned according to Art. 22a of Directive 2001/83.
This service is a voluntary option for marketing authorization holders and applicants. It follows the routine scientific advice procedure but involves PRAC experts. As with routine scientific advice fees are charged on initial as well as on follow up requests.
Read more:
http://bit.ly/European_Medicines_Agency_Postauthorisation

06/09/2016

Within the context of post-marketing surveillance and risk management non-interventional studies (NIS) gain more and more in importance.
Whether to elucidate further safety profiles or to evaluate product usage in daily practice: non-interventional studies are the method of choice for the generation of “real world evidence”. Results obtained from NIS have major impact on product authorizations and the product life cycle – thus study conduct on a high quality level becomes a critical factor.
The team of S2 ScienceSolutions offers the following services – either as a package solution or individual service – for non-interventional studies. We are pleased to support commercial and academic projects likewise in this sector.

For further information visit us on:
http://www.s2sciencesolutions.com/en/