Medical Writing Expertise Is at the Heart of Your Regulatory Submission
Altasciences’ experienced team of writers offers clinical, medical, and regulatory expertise to help you document your drug’s efficacy and safety—always in compliance with current regulatory guidelines. Our team’s strengths in project management and scientific operations ensure integrated processes that facilitate the transfer of data and knowledge into the required documents for each stage of your clinical trials, including initiation, conduct, completion, and reporting
We collaborate closely with your team to create complete and accurate study protocols, protocol amendments, patient information and informed consent forms, clinical study reports (CSRs), and biostatistical, safety, and bioanalytical reports.
Whether you are looking for medical writing as a stand-alone solution or to support an entire study program, we are ready to partner with you.
- Strategic therapeutic and indication-specific collaboration, from study concept and design to final study report and submission
- Active and routine engagement and consultation with statistical, medical, and scientific experts
- Scientific and operational team with close to 30 years of experience conducting clinical trials
- Standardized and ICH-compliant processes for document development
- Robust QC review of documents against source data and documents
- Protocol synopses
- Protocols (and amendments)
- Informed consent forms
- Clinical study reports and addenda/amendments
- Safety reports
- Marketing application summary documents for NDAs/BLAs
- Investigator Brochure
- Briefing books
- Annual reports/DSURs
Bringing Your Data to Life
Our medical writing experts have extensive experience covering a wide range of therapeutic areas, for small and large molecules. You can rely on our dedicated medical writing experts to design, prepare, write, proofread, edit, and format the full array of documents required for the smooth conduct of your clinical programs and facilitate submission of data worldwide.
Clinical Trial Protocol and Amendments
Our dedicated, highly skilled, multidisciplinary protocol-development scientists have expertise in clinical pharmacology, pharmacokinetics, and diverse therapeutic areas. They collaborate closely with our team of clinical, medical, and bioanalytical experts, biostatisticians, and drug development scientists, to develop and deliver high-quality clinical trial protocols covering a wide variety of dosage forms and study designs. We leverage preclinical data to guide us in designing studies from first-in-human to clinical proof-of-concept. Experienced in the ethical and regulatory requirements of North America, Europe, and Asia, we offer a global solution to your protocol development needs, from conceptualization to development, providing consulting services as well as comments and direction on strategies for Phase I, IIa, and NDA-enabling clinical pharmacology studies.
Clinical Trial Reporting
Our report specialists collaborate closely with our pharmacokinetic scientists, biostatisticians, principal investigators, and other subject matter experts, to consistently provide complete and accurate interpretation and reporting of clinical data. With our medical writers’ clinical and scientific expertise, they extrapolate relationships across safety and PD data to ensure accurate assessment of proof-of-concept and safety during each stage of drug development.
Our reporting team ensures that all your specific publishing requirements are applied. In addition, we certify that all appropriate submission and regulatory standards are met for fully integrated ICH-compliant clinical study reports, and other scientific reports as required.
Scientific Publication Writing
Our scientific experts provide strategic guidance and quality writing for your scientific publications on nonclinical and clinical research topics, and a wide range of therapeutic areas. Benefit from content development for manuscripts, posters, and abstracts, and expert review and editing of your pre-written publications.
Other Regulatory Documents
Investigator’s Brochure (IB) We recognize that an IB serves as a comprehensive source of information about your investigational product and its clinical trial. Leveraging our expertise in scientific writing and regulatory guidelines, we collaborate with you to develop a detailed IB that provides essential information to investigators, ethics committees, and regulatory authorities. Throughout the IB preparation process, we ensure that the content is scientifically accurate, up-to-date, and tailored to the target audience. We meticulously review the available data, clinical trial information, and relevant literature to provide a comprehensive overview of your investigational product’s development and its implications.
We ensure that the IB adheres to international regulatory standards, including ICH guidelines, and that it provides a comprehensive resource for investigators and regulatory agencies to assess the investigational product’s safety and efficacy.
8-Factor Reports
Recognizing the critical importance of evaluating abuse potential in the development of new medications, our experts analyze nonclinical and clinical data to gauge the likelihood of substance abuse and addiction. We offer strategic insights that can inform crucial decision-making throughout your drug development process, always in line with regulatory guidelines.
Briefing Book
Our expert team is dedicated to crafting comprehensive and curated briefing books tailored to meet the unique needs of your research endeavors. We understand these documents' pivotal role in communicating essential study information to regulatory agencies, investigators, and key stakeholders. Our approach combines precision and efficiency, ensuring that your briefing book adheres to rigorous regulatory standards and is a strategic tool for effective communication and decision-making.
IND Development
IND applications play a significant role in obtaining regulatory approval for clinical trials, and our experts are equipped with the knowledge and experience to ensure a seamless and successful submission. From assembling comprehensive nonclinical and clinical data to crafting a compelling narrative that aligns with regulatory requirements, our service is designed to meet and exceed industry standards.
At Altasciences, we deliver the materials you need rapidly, without compromising on quality—from your study design to your final clinical study report.
EXPLORE MORE OF ALTASCIENCES’ CRO SERVICES
Advancing your drug candidate smoothly to proof of concept is what we do best.