Scientific Writing
Medical Writing at RLS includes regulatory, marketing, and educational document writing services and we can undertake all medical writing services for Phase I to IV studies.
we are capable enough of writing SOPs and develop scientific posters and manuscripts as we have expertise in developing educational material as print form or web-based learning systems and promotional material for our clients’ sales and marketing efforts.
Our medical writing team comprises 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 prepared by us are in accordance with standard operating procedures and templates, and customised as per sponsor specifications.
Documents are prepared strictly in accordance with ICH/EU/US guidelines and regulations.
Protocol Design:
- Protocol Design staff of RLS 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 ensure that new developments in the specific field are addressed.
- We 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
Essential Clinical trial documents:
- RLS creates clinical trial documents such as the clinical trial protocol, investigator brochure, clinical study report, informed consent and patient information sheet, trial master file, Investigator master file, Investigator site file, vender file, annual reports and patient event summaries. Product Information Brochures, Abstracts, Posters, Manuscripts, Scientific/ promotional texts, as well with ease & accuracy at the same time.
