Medical Writing
Whether you are conducting clinical trials or marketing a new product, our medical writing team has the experience and technical knowledge to help you. We can give you expert advice on the preparation of regulatory and clinical research documents at every stage to ensure that the process runs smoothly.
Our team is experienced in many therapeutic areas and is familiar with a variety of writing styles. We provide support either as part of a full-service contract or focus on individual writing projects. While we can provide fully ICH GCP-compliant templates for all standard documents, we are
comfortable using
your own templates. We offer a wide range of medical writing services, including preparing clinical study reports, protocols, subject information sheets, narratives, clinical overviews and summaries, manuscripts, editing, abstracting, translations, literature searches and reviews, training materials, poster presentations, conference and workshop reports, and product monographs.
Regulatory Writing |
Investigator Brochures (IBs)
We have the ability to prepare original IBs or update existing brochures. We can summarize the non-clinical data as well as any available previous human experience information. Many of our IB projects are included as a component of our IND preparation.
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Protocols
Our staff has experience with all aspects of protocol preparation, from developing the initial study design to writing the protocol from a study outline provided by the client. Our experience includes protocol writing for Phase I-IV clinical studies, adult and pediatric indications, orphan indications, and other indications for which there is very little prior knowledge or experience in terms of study design.
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INDs and CTAs
Constella can plan, prepare, review, compile, and submit your IND/CTA. We are often involved at the pre-clinical stage of projects and can assist with the non-clinical, clinical, and regulatory strategy for your submission. We can also organize and participate in meetings with regulatory agencies. Our projects often include preparing protocols for the initial study as well as development of the Investigator Brochures.
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Clinical Study Reports (CSRs)
We author clinical study reports for clinical trials we conduct or for studies with which we have had no prior involvement. Constella has extensive experience with preparing CSRs for Phase I-IV studies. We can provide the statistical analyses or write the report from a client delivered statistical package. We have clinical study report templates that meet ICH guidelines, and we are equally comfortable working with our clients’ standard report templates.
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NDAs/BLAs and MAAs
We have the capability to plan, prepare, review, compile, and submit your NDA/BLA or MAA submissions in CTD format.. Our typical involvement is with the clinical components, although we can assist with non-clinical aspects as well. Constella can help with the strategy, including preparing for the meeting with the agency. Our projects often include preparing clinical study reports in conjunction with the regulatory submission.
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Non-regulatory Writing |
Publications
Constella develops abstracts, full manuscripts, or review articles summarizing the results of Phase I-IV studies focusing on particular scientific and clinical issues. We can develop manuscripts for publication from a clinical study report or directly from a statistical package. Our staff can work directly with the lead author/investigator. We offer recommendations on target journals and can assist with preparation of the submission package and required journal revisions.
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Marketing and Sales Support Materials
We can develop sales training materials and other product support information. We have a good understanding of the interplay between clinical and commercial objectives which facilitates our ability to prepare materials for physician, patient, and/or client audiences. |
