High-end Medical Support during the Whole Product Lifecycle

Patient Recruitment

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.

Services

Country and site level feasibility
Development and set-up of patient recruitment strategy aimed to meet anticipated enrolment speed
Development of recruitment materials, including digital and non-digital advertising options
Investigator education focusing on achievement of patient commitment
Set-up of patient reimbursement process
Enrolment Liaison Manager (ELM) service aimed to improve Investigator's engagement

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.

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