Turnkey Provider

Scalable & Flexible

Client-dedicated

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For 15 years, we have been providing strategic, responsive, and flexible medical writing and editing project support.

Our clients have valued the continuity provided by our writers and editors and have benefited from their seamless integration into the project study teams.

Whether you need adjunct support for individual medical writing deliverables or to outsource all medical writing across an entire development program, our expertise and experience can be leveraged to ensure all your project goals are achieved.

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The most proficient medical writer I have worked with.

“The medical writer’s ability to summarize data and word the interpretations of data is second to none. On the few occasions that I suggested wording as a starting point, she was always able to improve upon it effortlessly, making it flow clearly and concisely. She is the most proficient medical writer I have worked with and I look forward to having the opportunity of working with her again in the future."

Medical Writing and Editing Client

Medical Writing & Editing Services

Our medical writers and editors are experienced professionals with advanced degrees and ELS certifications whose proficiencies span a vast array of document types.

They have logged thousands of hours working side-by-side with clients and this seamless integration has often resulted in Kateric resources being requested by name by the project teams.

Medical Writing

Comprehensive medical writing and project management services for all clinical and safety documentation required throughout the drug development lifecycle as well as other scientific communications.

Medical Editing

Complete top to bottom editorial review of each deliverable ensuring consistency, clarity of message, and appropriate implementation of all required styles and templates.

This review can be performed in addition to a quality control review or as a standalone review.

Our Medical Writing & Editing Therapeutic Areas

The areas of expertise combined across all Kateric resources encompasses therapeutic areas including
(but not limited to):

  • Oncology
  • Inflammation
  • Infectious diseases
  • Rheumatology
  • Ophthalmology
  • Dermatology
  • Pulmonary and respiratory diseases
  • Cardiovascular
  • Endocrinology
  • Gastroenterology
  • Hematology
  • Neurology/CNS
  • Psychiatry
  • Vaccines
  • Pain and sensory
  • Immunology
  • Urology
  • Nephrology
  • HIV/AIDs
  • HCV
  • Cell therapy
  • Autoimmune disorders

Willingness to take full ownership of the writing

What I particularly liked about working with the Kateric medical writer was her willingness to
take full ownership of the writing no matter the complexity of the subject matter.
All previous writers I have worked with would have asked me to suggest text in these
circumstances. It was refreshing to work with somebody as competent and reliable as her.

Medical Writing and Editing Client

Our Medical Writing & Editing Deliverables

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Our medical writing portfolio encompasses execution of hundreds of deliverables spanning all types of clinical, safety, and other scientific communication documents, including but not limited to:

Clinical

  • Investigational New Drug applications (INDs)
  • Orphan Drug Application
  • Pediatric Investigation Plans
  • Pediatric Study Plans
  • New Drug Application (NDA)
  • Investigator’s Brochures (IBs)
  • United States Prescribing Information
  • Summary of Product Characteristics
  • Pre-Meeting Packages/Briefing Packages
  • Protocols
  • Informed Consent Forms (ICFs)
  • Clinical Study Reports (CSRs)
  • Real World Data Documents
  • Common Technical Documents

Safety

  • Development Safety Update Reports (DSURs)
  • Periodic Benefit Risk and Evaluation Reports (PBRERs)
  • Patient safety narratives

Other Scientific Documents

  • Scientific manuscripts
  • Posters

Benefits of Working With Our Medical
Writing & Editing Team

Global

Located across all US time zones, in the EU, and in India.

Highly Experienced

Our medical writers and editors have an average of 8 years of writing experience and most have advanced degrees. Their industry background includes CRO, big pharma, NIH, and JAMA.

Client-Dedicated

They remain on a project from start to finish, working only for a single client at a time.

Scalable

With access to a large pool of experienced resources, we can scale up as needed to accommodate any demand.

Quality Focused

Quality is intentional and is created, nurtured, and cultivated. Using a documented and systematic approach, we build quality into each document as it evolves through its lifecycle.

Adept Project Managers

Experience managing deliverables from start to finish, accountable for coordinating all aspects of input, production, and review of the document.

Excellent attention to detail

“The medical writer had excellent attention to detail. Her first draft was of excellent quality…she was
very helpful assisting the clinical scientist and study statistician in how best to word the interpretations.
It was clear to me that she has a lot of experience and is a very able writer.”

Medical Writing and Editing Client

Medical Writing & Editing Frequently Asked Questions

What industries do you specialize in?

We provide medical writing services to pharmaceutical/biotech companies of all sizes (including small, mid-size, and big pharma), and contract research organizations.

What does oversight and project management of deliverables
look like at Kateric?

Service oversight by Kateric includes internal project oversight of assigned resources, project management, metrics, scheduling, issue resolution and escalation, internal training, and frequent meetings with the client over the contract term. As part of this joint oversight, Kateric works with each client to develop an oversight plan establishing parameters for governance and project oversight.

Project management of deliverables is facilitated through the use of an online metrics tracking program. This system allows us to perform multiple tracking tasks (e.g., scheduling, tracking project timelines, tracking compliance with training, etc.).

At both the deliverable and milestone level, examples of information that we have tracked include on-time completion, hours spent, and resource allocation. Relevant data are extracted at a more granular and detailed level and used by Kateric to report on key performance indicators (KPIs), which can then be provided to the client in a quarterly business report.

A key feature of this system is that it provides real-time visibility to our clients, so they can see the status of each of their projects at any given time via an online dashboard. The information collected and presented is customizable allowing each client to see what is most meaningful and important to them.

What is the general process of authoring a document—from the request from a Sponsor through the completion of a document?

The Kateric process is an "author-driven" process that can be modified and customized to meet specific client needs. In the Kateric process, the author works with the cross functional/multidisciplinary team during the preparation and development of the document, engaging at a level agreed upon with the client (i.e., can be as much or as little team involvement, depending on business need, team bandwidth, etc).

Generally, the Kateric author maintains responsibility for and manages the review process, including comment incorporation and adjudication. Once the document is drafted and has been reviewed by the team, the Kateric author facilitates the necessary quality reviews (either internal to the Sponsor or within Kateric) as well as any publishing/approval cycles, as necessary.

The overall project goals for each deliverable are to meet timelines, manage challenges, produce a high-quality document, and minimize cost.

Develop Timeline

  • Initial contact
  • Establish team expectations, key messages, and document strategy
  • Identify potential risks; establish risk management plan as applicable

Draft Summary

  • Collect study documents
  • Work in collaboration with author team to ensure appropriate content and quality
  • Follow communication plan

Manage Review Cycle

  • Adjudicate and incorporate review comments in collaboration with team
  • Ensure timeline integrity

Finalize

  • Complete author review (checklist)
  • Facilitate final quality review and document publishing

Internal Distribution

  • Obtain final approvals
  • Distribute document

Do your writers and editors generally work directly with the
cross-functional teams?

Yes, all Kateric writers are very experienced working with global cross-functional teams as they do this as part of our standard medical writing process.