KPS CLINICAL SERVICES

Clinical Trial Training
Preclinical Study Centre
Bioequivalence Study Centre
Regulatory Affairs
Investigator Registration

MEDICAL WRITING AND TRANSLATION

Scientific Writing

Medical Writing at KPSCS includes regulatory, marketing, and educational document writing services and we can undertake all medical writing services for Phase I to IV studies.

we can can also write 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 customized as per sponsor specifications.

Documents are prepared strictly in accordance with ICH/EU/US guidelines and regulations.

our document reviewes includes:-

Peer Medical Writers
Biostatisticians
Project Managers
Regulatory professional
Quality Control officers

Every document is prepared in close association with sponsor's 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 KPSCS personnel with medical/ pharmaceutical 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 KPSCS 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

KPSCS 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.