The Medical Writing Solutions team at White Globe carefully develops accurate messages for a variety of audiences. We get into the details to deliver everything with complete regulatory compliance, whether it’s creating protocols and informed consent forms or a new drug application.
Our vast team of writers can smoothly expand (or fully develop) your scientific, technical, medical, regulatory, and commercialization communications through our adaptable outsourcing options.
Our Medical Writing Solutions Team:
• A proficient global writing team with familiarity with local laws and the capacity to create multilingual communications as required.
• Provides the flexibility to put together the right team with the relevant areas of concentration and a single point of contact.
• Manage and optimize document development to meet timelines.
• Offers guidance with open advice on clinical documentation, including publishing and submission readiness.
White Globe has a thorough understanding of many regulatory standards, including the ICH-GCP, FDA, and EMA standards. Our team is made up of experts with training in a variety of therapeutic fields, including medicine, pharmaceuticals, and other life sciences (MBBS, MD, PhD, and Masters). Our medical writers receive ongoing training from professional organizations, and they can assist you with creating reports and documents that are precise, succinct, and of the highest quality.
Protocols, synopsis, ICF, IB, CSR, patient/safety narratives, clinical summary/overview, non-clinical study reports, non-clinical summary/overview, annual/periodic safety reports, manuscripts, abstracts, medical information documents, etc. are some of the writing types we concentrate on in the field of medicine.
Our medical writers have years of hands-on experience, and they are skilled at comprehending and analyzing complex medical facts and data (clinical, scientific, non-clinical, and safety), as well as creating complex documents with the appropriate standards. Competent Subject Matter Experts (SMEs), biostatisticians, data analysts, quality analysts, and an editing and language support staff support them in this process. To reduce your QC or supervision workload, an independent QC team assures additional inspection before the papers are submitted to you.
A verified web-based document management system is used to manage, generate, access, share, modify, and store all documents.
Copyright ©2024 WHITE GLOBE GROUP PVT LTD