MDD-MDR challenge

Medical devices in Europe have been regulated by the Medical Device Directive (MDD), directive 93/42/EEC. As it can be seen from the directive’s number it dates back to 1993. It has over the years been modified, latest in 2007. So, until now medical devices have been regulated by decade old directives.  It might have been through this fact that several scandals have been recovered within the medical device industry over the years. In the late Læs mere…

The eTMF challenge

We at CIMS have a long history within the pharma and biotech business. We have over the years come across many companies that have asked for our advice for eTMF systems. For those not familiar with the term eTMF it stands for electronic Trial Master File.  A trial master file (TMF) is the collection of essential documents that is used for the management of the trial and used to verify whether the sponsor and the Læs mere…

CIMS in Pharm Tech Outlook

CIMS is top clinical management company in Europe CIMS has been awarded in the annual listing of top 10 companies that are at the forefront of providing Clinical Trial Management Consulting/Service and transforming businesses in the journal Pharma Tech Outlook. The award means that CIMS has been granted a cover story of the recognized magazine. Read the article here!

Supply Chain Management production pull

Outsourcing of production has become a significant risk Take back control over your production and Supply Chain Management based upon risk based selection of process elements. Use  ISO 9001:2015 and PDCA process to implement process elements in your own control. Risk Based pull back production process elements requires insight in the full process Information collection and controlling information flow, data models, analysis, process, systems integration, regulatory requirements, statistical methods, knowledge management, Quality Assurances and Control, CMO Læs mere…

Certified Lead Auditors

CIMS is CQI/IRCA(1) certified as lead auditors within ISO 9001:2015(2) to support our domain specialty of the drug development process and data sciences.  We use the Quality Management Systems (QMS) as the foundation for the drug development process establishment, continuous improvement and anchoring.  The QMS will be the centre point of our data handling and data sciences reflecting regulatory requirements.  Since we are certified lead auditors, we would be happy to conduct or assist you with any internal, Læs mere…

Outsourcing has become a significant risk

Take back control over your data Risk Based selection of clinical data process elements requires insight in the full process Information collection and controlling information flow, data models, analysis, process, systems integration, regulatory requirements, statistical methods, knowledge management, Quality Assurances and Control, CRO integration, Patient Safety and GVP, Cost reduction, Reducing time consumption, Information Management. Select the right elements and pull execution of those back inhouse Take back single elements of the outsourced clinical Drug Læs mere…

CIMS Reporting Apps

Tracking of Operational progress and development depends upon quality data and it’s availability CIMS Reporting Apps establish the connections needed CIMS reporting Apps is integration between Company process Planning KPI integration Apps deployment Establish reporting functions for all layers in the company Monitoring Progress and Quality FSP integration CIMS Report Apps Will generate all necessary reports on an automated basis with client specied internals. Daily, weekly, monthly etc. Based on scientic statistical tests and Articial Læs mere…

Data Protection System

Ensures you are in compliances with GDPR when working with vendors outside EU Also, when subsidiary parties to your vendor are processing your data GDPR data exchanges control outside EU can be very cumbersome and very worrying. Transfers of personal data to third countries are regulated under Articles 44-50of the General Data Protection Regulation (Reg. EU 2016/679). Adequacy Decision is how Non-EU countries has an adequate level of dataprotection. Where the transfer is to a Læs mere…

Clinical Informatic

If you control your data you control your studies and programmes CIMS Clinical Informatic is:Knowing where every piece of data is at a given timeKnowing who needs what information at what timeLearning from data continually and foresee obstacles before they happenEnabling and facilitate control CIMS Clinical Informatic in context Clinical Informatics is Supply Chain Management applied on Data and Information Information Logistic (IL) Information Supply Chain Management (ISCM) Data Inteligence (DI) Information Logistic (IL) is Læs mere…

CDISC Implementation and Governances

CIMS can help you with all the challenges of information model management in CDISC CDISC is not just about having the right model is also about: Governances of data standardsGovernances SOPsImplementation CRO data exchangesMap against your CROs data models Statistical facilitationMaintain exibility within the borders and rules of governances Agility of data model upstream in CRFs Why is it complicated? It’s complicated because SEND must balance and integrate requirements and constraints coming from Existing data Læs mere…