frequently asked questions
Who are dn8 collaborate?
dn8 collaborate is a boutique Contract Research Organisation that specialises in providing comprehensive clinical trial biometric support and solutions to the pharmaceutical, biotechnology, and medical device industries. The company was formed as an extension of its parent company which has specialised in clinical research consulting since the beginning of 2016. dn8 collaborate provide support in the following areas including full study set-up, data management, statistical services and medical writing.
dn8 collaborate know how important your clinical trial is to you and we manage your clinical data as if we were a fully integrated member of your clinical trial team.
We provide regular communication and comprehensive management, from input in to the protocol all the way through to reporting, on time and within budget.
What type of clinical studies have dn8 collaborate worked on?
dn8 collaborate have managed clinical trials in the following therapeutic areas:
- Phase III oncology
- Phase I metabolic
- Phase II infectious disease
- Phase I cardiovascular
- Phase I autoimmune
- Phase I respiratory
- Phase II respiratory
How do dn8 collaborate ensure data is safe?
dn8 collaborate use the Egnyte Connect cloud-based collaboration solution which provides 256-bit AES encryption to encrypt data during transmission plus fully redundant application setup that is resilient to hardware and network failure. The server storage is in an industry-leading Tier III, SSAE 16 compliant co-location facilities that feature 24-hour manned security, biometric access control, and video surveillance.
How do dn8 collaborate manage a clinical trial?
dn8 collaborate project manage all aspects of data management of your study from set up, through conduct, to close out. We understand the importance of timely and qualitative delivery of tasks and we manage this with a proactive approach. We assign a Project Data Manager, we add experienced problem solving, accurate budget management and detailed timeline and reporting to your trial.
As we define a communication plan at the very beginning of our involvement in your trial, we define the risks as well as the mitigations proactively. We provide detailed individual task budgets which are monitored and communicated at 25%, 50%, and 75% of each task completion. This allows for robust budget management and proactive solutions.
Our contemporaneous collaborative cloud office models allows us to select the appropriate Project Data Manager for your clinical trial and its geographical location. In addition to this, our model negates the impact of actual billability on an organisation thus mitigating the use of change orders unless there is a change in scope.
dn8 collaborate What operational support can you offer?
dn8 collaborate operational staff are task-based resource and are fully scalable around the complexity of your clinical trial. Operationally, we are aligned with ISO 9001, ISO 27001, 21 CFR Part 11 and GxP. We offer CDISC expertise around SEND, SDTM, ADaM, Annotated CRFs, DEfine XML, SDRG and ADRG. We can offer the following Electronic Data Capture (EDC) technologies (build and management):
- Medidata RAVE
- Oracle InForm
We offer insights in to your clinical trial through robust data review plans that are linked to both clinical trial and clinical operations digital visualisations.
How can we contact dn8 collaborate?
Contact us today to discuss your requirements and let us provide you with a bespoke solution tailored specifically to your biometric needs.
About our CEO
Stuart Cook has over nineteen years' data management experience within the pharmaceutical and CRO industry in phase I-IV clinical trials including oncology, respiratory, paediatric diabetes, depression, rheumatoid arthritis and epidemiology therapy areas. Stuart performed as a global director of Clinical Data Management before leading the development of a consultant specialising in Clinical Data Management. The success of this consultancy led in turn to the development of dn8 collaborate.
"Adding to the existing knowledge and experience gained within the industry, I took a detailed look over 3 years, at the current CRO market in combination with rise of the cloud office. I truly believe that the model that dn8 collaborate have developed allows us to concentrate on the relationships with our clients. We are transforming the Contact Research Organisation in to a Collaborative Research Organisation through open and transparent communication, and risk strategies" Stuart Cook 2019