Our CRS medical writing team combines more than 40 years of experience in early phase trials. A smooth transition from laboratory to first steps in human clinical trials is crucial in the development of a new drug. Our medical writers support you at each step: from the briefing documentation for scientific advice, in preparation of the study, up to the submission-ready clinical study report.
We fully understand the key challenges of early phase studies, e.g., the high level of uncertainty, the sparse and sometimes daily changing information to build on, the needs of multifunctional teams, and this all within short turnover times.
Our CRS medical writing team key expertise is to plan, organize and conduct early phase studies, such as
Incidentally, it shall be mentioned, that our CRS medical writing team was involved in the development of one of the first biosimilar trials (filgrastim).
We are well prepared to support global enterprises as well as small startups and virtual companies.
Our scope of services can be scaled to our client’s needs – from document reviewer to fully fledged medical writer.
We work according to our own procedures and templates but we are also flexible to work according to Sponsor’s procedures and templates.
Our CRS medical writing services range from support in early trial planning up to the publication of study results – and all what is needed in between.
When seeking scientific advice from competent authorities, high-quality briefing documentation is essential for outcome and value of the advice. Especially in the early stages of a clinical development project, many open questions arise where scientific advice can help moving forward faster.
Customers’ satisfaction is a top priority for CRS and is regularly surveyed. CRS likes to share with you some exemplary quotes from customers:
“I enjoyed the very professional collaboration.” “The team met challenges on the fly.” “The workflow was very smooth. The colleagues were responsive, showed self-initiative, and offered good solutions.” “Very flexible”.
Inauguration, supervision and support of the safety monitoring board.
The clinical study protocol is the central document of a clinical trial, which contains essential information on planning and conduct of a trial, and the underlying scientific and regulatory rationale.
On customer’s request
On customer’s request
CRS medical writers care for a perfect presentation of results.
We combine scientific background with linguistic and editorial expertise.
Our medical writers work hand-in-hand with the clinical teams of the CRS study units and along with the sponsor’s teams in order to ensure internal and external seamless communication and to guarantee scientifically sound protocols and clear-cut reports.
Advice is sought
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