Medical Writing and Translation

Medical Writing at RCRS includes regulatory, marketing, and educational document writing services. RCRS creates clinical trial documents such as the clinical trial protocol, investigator brochure, clinical study report, informed consent and patient information sheet, annual reports and patient event summaries. RCRS can undertake all medical writing services for Phase I-IV studies.

RCRS can also write SOPs and develop scientific posters and manuscripts. It also has expertise in developing educational material as print or web-based learning systems and promotional material for our clients' sales and marketing efforts.

The Medical Writers consist of a team of physicians who have experience in developing documents in various therapeutic areas such as oncology, cardiology, infectious diseases, ophthalmology, diabetes, neuropsychiatry and respiratory disorders. Documents are prepared in accordance with standard operating procedures and templates, and customized as per sponsor specifications.

Documents are prepared in strict accordance with US/EU/ICH guidelines and regulations. . Document reviewers include peer medical writers, biostatisticians, project managers, regulatory specialists and quality control specialists. Every document is prepared in close association with sponsor representatives. Typically the turn-around time for a clinical study report is 3-4 weeks.

The medical writing group has access to excellent translating services ensuring a fast turnaround time for clinical trial documents ranging from patient information to diagnostic tools and Investigator Brochures. The translation process is coordinated by experienced RCRS personnel with medical/ pharmacy expertise to ensure accuracy and consistency in content and style leading to quicker submissions and earlier study start-up.

Protocol Design
Protocol Design staff of RCRS designs product development programs in consultation with medical, biostatistics and regulatory experts. It can assist in the planning of pre-clinical testing and clinical studies, and assist in the interpretation of study data. Clinical trials are designed with a view to provide a suitable fit within your overall development strategy for your product. Consultation with opinion leaders in the specific therapeutic area during the development of the protocols helps to maintain a practical approach to study assessments and ensures that new developments in the specific field are addressed..

RCRS also offers consultation in product development and marketing strategy. Such consultation represents current industry practice, reflects "best practices", and assures compliance with all applicable regulatory requirements.

RCRS offers consultation in the integrated development of sustainable quality systems to standards such as ISO 9000, GMP and EN 46000 as well as in the design, implementation and management of effective Corrective Action Plans. Due diligence reviews of suppliers can also be conducted in a cost-effective and a benefit-driven manner.

Marketing Material
RCRS also provides services for preparation of marketing material such as Product Monographs, Patient Information Leaflets, Product Information Brochures, Abstracts, Posters, Manuscripts, Scientific/ promotional texts, Press releases, Publications and Query Management-related documents. The RCRS Medical Writing group has access to Aculaser printers and other equally high-end printers ensuring a quick turnaround time and quality.

RCRS defines, delivers and manages powerful publication plans in order to disseminate your clinical information to appropriate thought leaders and therapeutic class specialists at the right time and via the right vehicles.

Post-Marketing Surveillance
RCRS offers a suite of post-marketing surveillance services to help sponsors collect, compare, process, track, and report adverse events. These services include the following components:

Call Center - to triage and collect event data
Literature search
Coding and training and consulting in coding
Data processing and reporting to regulatory authorities
Periodic Safety Update Reports
Post-Approval Services:

In addition to post-marketing surveillance, RCRS offers additional services designed to help the customer stay within all appropriate regulations, and to help the customer identify new opportunities for an approved product:

Review of promotional materials
Review of label changes
Off-label uses and promotions
Strategic planning for new indications