They possess strong project management and negotiation skills and support projects with multiple customer contributors and external thought leaders.They drive timelines, organize and lead authoring meetings, and reconcile sponsor feedback across functions to create consistent, scientifically cohesive documents and minimize nonessential customer oversight.Tags: Duke University Sex ThesisAny Essay WritingPublished DissertationsHow Write Research ProposalEssay On AeroplaneCreative Writing InstructionWhat Are Economic Goods In Terms Of EconomicsTheme Essays The CrucibleDeveloping Argument Essays
As Regulatory authorities expect precise and timely submissions of documents/dossier, any delay in this stage leads directly to a delay in realizing profits both in terms of achieving patient benefit and ROI.
With a qualified (Medical and Paramedical) team of skilled and experienced medical writing professionals from pharmaceutical and clinical research industries, Freyr develops quality documents, performs peer review and coordinates client reviews, performs quality checks, and accomplishes the project management of various Regulatory, clinical writing activities in both Electronic Common Technical Document (e CTD) and CTD modules.
The FSP structure builds on our clinical and technical expertise to deliver not only high-quality deliverables, but also provides dedicated resources capable of fully integrating with customers’ teams, providing consistent compound expertise.
Our committed FSP leadership provides a performance management of the staff, focusing on developing and retaining personnel within the partnership; ownership of staff productivity; and collaborative process optimization, engaging with customers to explore opportunities for innovation and increased efficiencies within the partnership.
We draft wide range of documents for clinical trial submissions and other regulatory documents yoke with clinical research.
The documents we cover are investigators’ brochures, study protocols, Informed consent, patient narratives, safety narratives, CSRs, selected e CTD modules, development safety update reports (DSURs), periodic safety update reports (PSURs) and annual safety reports (ASRs).
Writers undergo regular training conducted by the EMWA (European Medical Writers Association), the AMWA (American Medical Writers Association) and other recognized medical writing organisations to keep their skills at the vanguard of the medical-writing field.
Felicitous and competent documentation is vital for the success of clinical development program.
These services can be offered on a stand-alone basis or as an integrated part of a clinical trial, drug development program or medical information service. All PPD documents undergo a rigorous review process to ensure that documents produced are of the highest quality.
A team of project-specific reviewers is selected to ensure the materials are grammatically correct, scientifically logical and completely accurate.