Insight Medical Writing is a dynamic and talented company with regulatory expertise at the core of our business.
Our vision is to be the ‘first choice for medical writing excellence’. For us, that means we always strive to provide accuracy, consistency and clarity. For our clients, that means support from a reliable, flexible and highly qualified team who deliver on time and on budget.
Working with Insight you have access to a group of talented, highly qualified and experienced writers who have written everything from GLP reports to CTD submissions, regulatory responses and Risk Management Plans. With a substantial team of 35 staff, Insight Medical Writing offers sufficient resource and flexibility to meet demanding timelines without compromising quality.
The Insight MW team has expertise spanning a broad spectrum of therapeutic areas. Our writers bring worldwide experience in areas including:
Data disclosure and transparency
Transparency in clinical development has been progressively formalised in legislation that requires data to be made publicly available in the form of lay summaries, data registries and redacted submission documents (including the Clinical Study Report, Clinical Summary and Clinical Overview). While information that is either commercially sensitive or might identify individual patients may be redacted in the public documents, this content must be agreed in advance with the appropriate authority, and achieving the right balance can be complex.
Insight is well placed to support and facilitate your data transparency obligations. We are proficient at preparing lay summaries, ensuring that often complex concepts are explained in a clear and easily accessible manner. Our writers have also been trained on the new redaction requirements and ensure a proactive approach is taken from the first draft, pre-empting and minimising the need for later efforts. In addition, our redaction specialists focus on tools, techniques and procedures that facilitate identification and justification of information to be redacted.
Clinical data are accurately and concisely presented for a variety of different audiences.
Clear, concise regulatory documentation is critical to the success of any drug development programme.
As a specialist writing provider with a proven track record of success, our wealth of experience in this area ensures smooth progress through submission to approval.
Global development programmes and international submissions require specialist translation services. Our partnership with a leading translation company ensures seamless transition between languages. We offer access to a broad team of translators who are well-versed in the requirements of the pharmaceutical sector, ensuring your documents are accurately converted using appropriate terminology. We understand the challenge of tight timelines, so final documents are formatted to allow direct incorporation by the publishing team.
Our dedicated team provides specialist writing support through each step of the development process. Precise, unambiguous documentation ensures successful implementation and completion of the clinical trial process. Our attention to detail is second to none.
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