Outsource Clinical Documentation, Medical Research And Clinical Study Report Writing Service-Outsourcing

 We offer the following as part of our clinical protocol documentation services: 

1     Clinical protocols and Protocol synopses writing

2     Advanced Clinical study report writing

3     Clinical investigator brochure writing

4     Safety expert report writing

5     Clinical summaries and overviews writing

6     Integrated clinical study reports for Phase I-IV studies writing

7     NDA/BLA, IND, NDS, ANDAA or MAA submissions

8     Briefing packages

9     Literature reviews and searches

10  Style guide

11   White papers and templates

We can handle your clinical study report writing according to necessary regulatory agency guidelines. Our intention is to fulfill client requirements in a timely, cost-effective and highly professional manner.  Our meticulous process ensures that client satisfaction is guaranteed in every project we undertake. We prepare documents according to standard operating procedures and we will customize them as per sponsor’s specifications. Clients can take up our services by a full-service contract or on individual project basis. 

Clinical Protocols Documentation Writers: We employ writers who are aware of all that is required as part of clinical protocol writing. They will adhere to regulatory operations and will ensure that their submissions, meet global standards.

Our teams of medical writers have advanced degrees and are experienced in many therapeutic areas. They are aware of a variety of writing styles and have considerable experience in preparing protocols and integrated clinical study reports for Phase II-IV studies. They are adept in developing investigator's brochures, serious adverse event reporting forms, patient consent documents, integrated summaries of safety and efficacy, case report forms, patient diaries, clinical study reports, for clients according to the required format. They are familiar with filling procedures and prepare ICH-compliant documentation in the style relevant to client’s specific medical field.

Contact us for Your Clinical Protocol Outsourcing Needs

Our intention in each project we undertake is to earn our clients' trust.  Contact us  to find out how we can assist you in your medical writing outsourcing project. Enquiry form