Medical Writing

From document review to fully fledged medical writing

Our CRS Medical Writing Team Supports You at each step

Medical writing

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

  • First-in-Human (FiH – 7 projects per year on average)
  • other early phase trials – BE, BA, DDI, FE, hepatic/renal, PD and biosimilar studies (25 projects per year on average).

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.

CRS medical writing

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”.

  • The Investigator’s Brochure (IB) is the most comprehensive document, which summarizes the development program of an Investigational Medicinal Product (IMP).
  • It contains relevant nonclinical and clinical data.
  • Structure: in accordance to GCP Section 6 & eCTD nonclinical and clinical part, guidance for the investigator, comprehensive risk-benefit analysis
  • It requires a concise, simple, objective, balanced, and non-promotional form.
  • Primary purpose: It provides a basis for the investigator to assess potential risks (and in later stages: benefits) associated with the IMP.
  • Secondary purpose: It provides information for the competent authorities (as  Investigational Medicinal Product Dossiers – IMPD) and the ethics committees.
  • Early phase: key document which supports the planning of First-in-Human study (starting dose selection, key measures to ensure safety of healthy volunteers) and other early phase trials (doses, dose escalation increments, dosing frequency, stopping rules, safety monitoring, early exploration of pharmacodynamic or efficacy parameters)

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.

  • Structure: in accordance to GCP Section 7, Transcelerate, SPIRIT
  • Primary purpose: describing all aspects of the trial on a scientific, medical, and organizational level
  • Reference for the competent authorities and ethics committees to assess the trial, and for the team to conduct the trial
  • Risk-benefit assessment for the specific trial and mitigation measures (subject protection, data validity)
  • Definition of the study population, measures and assessments to be taken, high-level summary of planned statistical analysis
  • Early phase: key document which supports the planning of First-in-Human study (starting dose selection, key measures to ensure safety of healthy volunteers) and other early phase trials (doses, dose escalation increments, dosing frequency, stopping rules, safety monitoring, early exploration of pharmacodynamic or efficacy parameters)
  • Comprehensive, easy-to-read document informing the trial participants about the trial and the risks and benefits to be anticipated from participation, allowing them making an informed decision on study participation
  • Lay language
  • Detailed description on data protection
  • Documented information for subject participants
  • One of the key documents for the ethics committees
  • Comprehensive description of the clinical trial conduct and results
  • Clear presentation of results, logical flow (results -> answer objective(s)? -> discussion -> conclusion -> generalizability, strengths and weaknesses of the trial, impact of deviations)
  • Early phase trials – exploratory trials // signal-to-noise ratio, finding what is important vs. confirmatory trials (bioequivalence, biosimilar)
  • All pursuant to ICH E3, CORE initiative, eCTD standards

On customer’s request

Characteristics and Skills of the CRS Medical Writing Team

CRS in Kiel Hepatology

CRS medical writers care for a perfect presentation of results.

Good Clinical Practice (GCP)

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. 

  • We understand the special requirements and have a sound knowledge of guidance framework for early phase clinical trials.
  • We know how to maintain the balance between comprehensiveness and readability and level of detail.
  • We understand bringing together the many disciplines involved in early phase document development – toxicologists, biomarker specialists, developers, clinicians, biostatisticians etc.
  • We are well aware, that early phase document development has special requirements on managing information flow and input/review.

Briefing Documentation for Scientific Advice with Competent Authorities

Advice is sought

  • when there are no guidelines,
  • when interpretation of guidelines requires support from authorities,
  • when the applicant wants to deviate from guidelines, or
  • when the applicant wants to receive advice on the best path for further development.

CRS supports you

  • in coordinating the contact with authorities,
  • in the development of the briefing documentation,
  • in collecting and compiling questions to the authority, and
  • in taking minutes of the scientific advice meeting.