High-end Medical Support during the Whole Product Lifecycle
%20(1).png)
Medical Services CRO
Dokumeds medical team has diverse therapeutic backgrounds, scientific expertise and many years of experience in clinical research required to provide comprehensive medical support during the whole product lifecycle.
Peer-to-peer communication between the Medical team and Investigators is the key. During clinical trials we build trusted relationships with health care professionals, generate their interest in the science behind IMP or device, increase awareness about Sponsor's medical strategy. It allows us to not only reach clinical trials milestones and ensure trial integrity, but also helps bridge the gap between clinical development phase and commercial success of the product after marketing authorization.
Medical Services by Dokumeds team during product lifecycle
Clinical Trial development phase
Medical Writer
- Developing clinical trial documents
- Developing regulatory documents to support submission to RA
Medical Monitor
- Medical review of protocol and other clinical trial documents
Enrollment Liason Manager
- Providing input into design in respect of enrollment
Clinical Trial conduct phase
Medical Monitor
- Medical review of eCRF and queries creating
- Reviewing AE/SAEs, coding of AE/SAEs and writing safety narratives
- Reviewing patient data to identify trends and risks across the study
Enrollment Liason Manager
- Developing recruitment plan
- Controlling enrollment speed on project / country / site level and action implementation
- Establish / maintain relationship with the site staff, patient organization
Post Clinical Trial phase
(before and after marketing authorization)
Medical Science Liaison
- Building relationship with KOLs
- Facilitating the exchange of scientific information within the context of a medical product ofr device
- Support to HCPs with the extended access / compassionate use programs
Connected services
Feasibility
We have been Feasibility Specialists for over 20 years. Sponsors contact us for specialist regional feasibilities, and oversight of global feasibility studies.
Learn more
Regulatory Affairs
Practice-based regulatory consulting expertise, and support throughout the product life cycle.
Learn more
Start up Services
Expert-led planning and design processes that will keep the trial on-time and on-budget
Learn more
Supply and Logistics
An established and cost effective logistics supply chain.
Learn more
