Medical writing support services include the creation, review and management of clinical and regulatory documents required to plan, conduct and report clinical trials and other health-related projects. These services ensure the accurate communication of scientific and clinical information to regulatory authorities, healthcare professionals and other stakeholders.
Protocol Development: Assist in the development of clinical trial protocols, including study objectives, design, methodology, statistical considerations, in accordance with regulatory requirements and industry standards.
Clinical Study Reports (CSRs): Summarizing the results of clinical trials, including efficacy and safety data, in accordance with regulatory guidelines and sponsor requirements Writing, reviewing and editing CSRs for.
Investigator Brochures: Comprehensive information about the investigational product, including pharmacological and nonclinical data, clinical experience, and safety profiles, for distribution to investigators and regulatory authorities. compiling and updating to provide information.
Informed Consent Forms (ICF): Ensure that study participants clearly understand the study procedures, risks, benefits, and rights before providing informed consent to participate in clinical trials. Development and review of informed consent forms to ensure
Regulatory Submissions: Including investigational new drug applications, new drug applications, marketing authorization applications, and other regulatory documents to support product approval and marketing authorization. Assist in the preparation and compilation of regulatory submissions.
Scientific Publications: Preparing and editing scientific articles, abstracts, posters, presentations for publication in peer-reviewed journals and making presentations at scientific conferences, accuracy, clarity and publication Ensuring compliance with the rules.
Clinical Trial Protocols and Amendments: Clinical trial protocols and protocol amendments to reflect changes in study objectives, methodology, or management and to ensure consistency with regulatory requirements and sponsor expectations. preparation, review and updating.
Patient Information Brochures: Provide patients with basic information about their medications or medical devices, including indications, dosage instructions, side effects and precautions, in clear and understandable language. Creating patient information brochures to provide
Quality Control and Assurance: Performing quality control checks on all medical writing outputs, including document format, content accuracy, compliance with timelines, and regulatory Ensuring compliance with requirements, industry standards and internal SOPs.
Training and Support: Providing support to internal and external stakeholders to increase efficiency, consistency and compliance in medical writing activities.
Ensuring the accuracy, consistency and compliance of clinical and regulatory documentation
Facilitated regulatory approval and marketing authorization for investigational products
Enhanced communication of scientific and clinical information to stakeholders
Better understanding and engagement of patients through clear and informative patient materials
Increased efficiency and productivity through streamlined medical writing processes and support
Medical writing support services offered by ALCOA provide comprehensive expertise and support to facilitate the creation, review and management of clinical and regulatory documents throughout the product lifecycle. Our team of experienced medical writers collaborates with sponsors to ensure accurate, compliant and timely communication of scientific and clinical information to regulators, healthcare professionals and patients.
