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Our services

DCB supports (patient) entrepreneurs, researchers and bigger corporates on their way towards market entry. Our specialised teams offer access to an international pool of experts, individual coaching sessions, clinical research and (pre-)seed funding. Submitted projects are evaluated within two weeks and professionally supported in case of a positive decision.

The DCB Service Portfolio accompanies you on your entire translational journey. Click through the offer and discover how the DCB and its network of experts can bring you closer to the market, step by step.

Would you like to know where you stand with your project and what gaps there may still be to fill before you can successfully enter the market? Choose the services that will bring you and your project forward in the coming weeks and months and exchange ideas with our diabetes tech experts.

Clinical Services

Contact our Clinical Team

Do you have an idea, a hypothesis that you would like to investigate in a clinical study? Do you need a clinical validation of your medical device? Would you like feedback on the study design, or are you looking for cooperation partners and specialists for a grant application?

Pre-study
Sample size estimation, study design
Feasibility (sites selection)
Definition of timelines
Contracting with MedTech, Participating sites, Collaborating groups
Protocol development
Development of study documents: Monitoring plan, data management plan, statistical analyses plan
Documents for subjects: ICF, diary, questionnaire…
Trial tools: authorization log, enrollment list, manual for study nurse
Setup of eCRF (design, programming, testing)
Submission (collection of required documents, upload documents in BASEC (Swissethics) or eMessage (Swissmedic), answer to EC/CA requirements)
Initiation visit (staff training, prepartion of IF…)
Medical device supply
Risk management (evaluation of risks and preparation of mitigation strategy)
During study
On-site monitoring
Central data monitoring
Safety: AE/ADE and SAE/SADE reporting, Device deficiency reporting
Site management
Preparation of amendment(s)
Submission of changes during study conduct (AM, new site, PI changes, safety reporting…)
(e)TMF maintenance
Deviation management
Interim analysis (constitution of IDMC)
Investigator meetings
Medical device supply
Support in case of site audit
Risk management (monitoring of mitigation strategy, update in case of AM)
Post study
Monitoring (close-down)
Database lock
Data management and data validation
Data preparation
Statistical analysis, contribution to final report
Submission final study report, notification of study termination
Support for publication writing, submission to journals
Anonymization of dataset
Archiving
Grant submission
Support development of grant application documents
Cost estimation

Lab Services & Facility

You would like to conduct a study or research, but lack the appropriate premises and services?

Our Lab & Facility Services
Clinical Facility Space
Overnight Clinical Space
Bio Safety 2 Lab
Office Space
Meeting Space
Project Space
Storage Space (-150C°, -80°C, -20C°, 2-8 C°, RT )
Storage and Environment Monitoring
Consumables Management
Medical Supply Management
Medicine Supply Management
Chemical Supply Management
Equipment Management
Experiment Setup Experience
Measurement System Analysis Experience
Root Cause Analyses and Investigation Experience
Laboratory Management
Safety Management
GLP (Good Laboratory Practice) and GCLP (Good Clinical Laboratory Practice)
Bioanalytics

Regulatory Services

Are you working on a medical device or medical device software and struggling through the regulatory jungle? Do you know the “intended use” of your solution? Are you unsure how your device is classified and what it needs for market access in Europe (MDR) and the USA (FDA)?

Our Regulatory Services
Quality Management System ISO 9001.2015
Deviation Management
OOX Management
CAPA Management
Change Management
Good Manufacturing Practice
Good Documentation Practice
Training Management
Risk Management
ISO 14155 Regulations
ISO 13485 Regulations
FDA / MDR go to market

Data Services

Contact our Data Team

Does your solution generate a lot of data and do you want to analyse it? Are you developing an algorithm and would like to exchange ideas with experienced specialists / validate the algorithm? Are you unsure how to process and visualise your data in a statistically correct way?

Our Data Services
Secure data storage – safe harbour for clinical data
Access to data
Validation of algorithm
Algorithm development
Statistical Analysis
CRF Design and Implementation

Business Services

Contact our Innovation Team

Do you have an idea, but are unsure whether and how it can be turned into a business model? Do you want to validate your business idea? Do you need a business case review? Do you want to start a company and are looking for selective support?

Our Business Services
Business Model creation and validation
User Research
Lean Startup principles
Project Management
Incorporation
Business Case validation
Marketing Strategy
Customer-/patient journey mappings
Product Development
Financial- and HR Services

Marketing & Communication Services

You have a brilliant idea or maybe even a product and nobody knows about it? Do you want to present your idea to potential investors and need support with your pitch? Have you wanted to use social media for a long time, but simply don’t have the time?

Our Marketing & Communication Services
Pitch Training
Communication strategy (holistic approach, internal and external communications)
Corporate communications
Social Media
Internal communication
Media relations
Visual content production
Copywriting (German and English)
Graphic design

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DCB Research AG

Freiburgstrasse 3
3010 Bern
Switzerland