MEDICAL WRITING

Clinical data transparency is an integral part of an ongoing effort to improve decisions for everyone involved in healthcare including patients, caregivers, healthcare providers, payers and regulators. The industry faces increasing challenge to develop practical methods to meet growing transparency requirements and compliance.

We are uniquely placed to provide expert, innovative, top quality solutions underpinned by a commercial model to minimise cost. We are the first company to offer end-to-end services in Clinical Trial Disclosure (CTD) (see figure below), bringing strategy and operations consulting, with a formalised full service business process outsourcing proposition for CTD.

Our Clinical Trial Disclosure Service Portfolio

The Eckrox CTD team actively track and advise clients on the potential impact of key regulatory reforms to align with evolving guidelines and regulations in US and Europe such as the EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing, European Union Clinical Trials Regulation, EMA policy for data transparency amongst others.

Eckrox subject matter experts bring experience across a broad range of therapeutic areas, successfully delivering on contracts of all sizes.

Eckrox subject matter experts bring experience across a broad range of therapeutic areas, successfully delivering on contracts of all sizes.

For further information on our services in CTD, please contact us at info@eckrox.com

CONCISE. PROFESSIONAL.

PHASE IIB-III CLINICAL TRIAL MEDICAL WRITING

Clear, concise, and professional presentation of study findings is an important factor in any development program. With a full complement of medical writing services, Eckrox Clinical professionals can provide all your documentation and writing needs. Comprised of scientists, many with advanced degrees, Eckrox team has significant expertise in key therapeutic areas of pharmaceutical and biotechnology clinical development. They work directly with you to ensure consistency with your format and style while maintaining full compliance with regulatory requirements and International Conference on Harmonisation (ICH) guidelines. Eckrox has a proven track record of timely delivery of quality medical writing deliverables coupled with outstanding customer service.

Eckrox FSP medical writing services are organized to provide medical writing services on a project-by-project or functional outsourcing basis. The functional service provider (FSP) model is characterized by dedicated resources — aligned by function, therapeutic area, or project phase — who work exclusively with a single customer. This model allows the dedication of a core team of writers with leadership focused on identifying and implementing process efficiencies. Eckrox maintains responsibility for overseeing and managing staff, but provides resources and leadership to move large portfolios of documents through the drug development pipeline.

Eckrox has good number of writers, editors, and writing management staff. Most of the writers (75%) are regulatory focused by training and prepare documents related to clinical trial conduct, reporting, and regulatory submissions. Fifteen percent prepare commercialization documents including abstracts, posters, manuscripts and medical information letters. The remaining ten percent focus on discovery, preclinical, technical or safety-related documents. They write hundreds of major documents every year, including protocols, clinical study reports, annual reports, investigator brochures, manuscripts, and posters. In addition, to 160 FTEs listed in the table below, Eckrox maintains contractual relationships with approximately 60 additional writers who perform writing services for us as needed.

Most of our medical writing staff is located in North America and we also have resources in India. Therapeutic experience includes neuroscience, oncology, cardiovascular, critical care, autoimmune, diabetes/endocrine, infectious disease, men’s health, women’s health, and osteoporosis/bone metabolism.

Let Eckrox Professional Writers Help You With:

REGULATORY WRITING

  • Protocols and protocol amendments
  • Informed Consent Forms/Patient Information Leaflets
  • Clinical study reports
  • Subject narratives
  • Investigator Brochures
  • Integrated summaries of safety/efficacy
  • Literature summaries
  • Clinical expert reports
  • INDs, NDAs, BLAs, CTAs (Module 2) summary documents
  • IND and NDA Annual reports
  • Safety Aggregate Reports (PSURs, PADERS, Line Listings, DSURs)
  • Clinical trial registry synopses

SCIENTIFIC MANUSCRIPTS

  • Manuscripts
  • Abstracts
  • Posters
  • Symposia publications
  • Slide presentations
  • Publication plans

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