Freelance Directory

Mr. Marc Roller

Marc Roller Consultant Medical Writer

Web:

Tel:
+49 6133 9242252
Mobile:
4916094985351

Grosse Fischergasse 11
DE-55283 Nierstein
Germany

Skills And Services Offered:

Examples of services:

Clinical:
• Clinical study protocols
• Clinical study reports
• Case report forms (including user acceptance testing)
• Medical coding (MedDRA, WHO-DD)
• Case narratives including EudraCT reporting
• Auxiliary documents (e.g., Monitoring manuals, SAE reconciliation plans, Laboratory manuals, Safety management plans)

Pharmacovigilance:
• DSURs
• PSURs/PBRER
• Subject narratives
• RSIs

Regulatory:
• Briefing books
• Clinical summaries
• eCTD Modules 2.5 and 2.7
• Clinical evaluations according to MEDDEV 2.7/1 v. 4

Other:
• Quality control and auditing

Subjects:

• Cardiovascular diseases
• Dermatology
• Diabetes
• Haematology
• Medical devices
• Multiple sclerosis
• Neurology
• Oncology
• Vaccines

Other Information:

Please do not hesitate to contact me without obligation to discuss potential projects and for a cost estimate.