SERVICES

 INCROE offers all medical writing services from Phase I to IV clinical studies. Our medical writing team comprises physicians and pharmacologists who have experience in developing documents in various therapeutic areas such as Oncology, Cardiology, Ophthalmology, Diabetology, Dental Science, Neuropsychiatry, Respiratory Disorders, Infectious Diseases, Dermatology, Hematology, Nephrology, Cosmetology, Ophthalmology, Antimicrobiological Agents, and Herbal Drugs.

Our team has expertise in scientific writing, abstracts, posters, manuscripts, and SOPs development. Documents are prepared strictly in accordance with ICH/EU/US guidelines and regulations.

The medical writing group has access to excellent translation services ranging from patient information sheets, Patient Diaries, ICD, CRF, Product Labels, Pharmacology Reports, Toxicology reports, Clinical Study Reports (CSR), and Investigator Brochures.

We provide translation services in 70+ languages.

 INCROE provides a regulatory affairs consultancy tailored to meet the client’s specific needs. The client’s data security and confidentiality are assured to the highest level.

Our regulatory team has significant global experience in the development of Dossiers, Drug Master File (DMF), and Common Technical Document (CTD).

We provide services from submission to final approval of regulatory documents at the office of DCG(I), FDA Bhawan, New Delhi.

We facilitate the guidelines for getting approval /

N.O.C. for the following applications:

• Bulk Drugs
• Finished Formulations
• Medical Devices & IVDs
• Vaccines

In short, we serve the entire spectrum of regulatory needs for our clients, based on experience and knowledge.

 INCROE provides comprehensive Clinical Operations and Monitoring services to ensure efficient, compliant, and high-quality clinical trial conduct. Our experienced team supports site selection, study initiation, monitoring visits, risk-based monitoring, data verification, protocol compliance, and timely issue resolution, ensuring participant safety, data integrity, and regulatory adherence. 

 Our Good Clinical Practice (GCP) workshop provides comprehensive, industry-relevant training that enhances regulatory compliance, research quality, and participant safety, equipping professionals with the expertise needed to excel in clinical research.  

 Prepare your clinical trial site for successful study execution with comprehensive training and site readiness support. Our program enhances GCP compliance, protocol understanding, regulatory documentation, investigational product management, participant safety, and quality systems. Strengthen operational excellence, improve inspection readiness, and ensure efficient, compliant, and high-quality clinical trial conduct.  

 At INCROE, we ensure that timelines are met and quality is maintained. Responsibilities, processes, and expectations are clearly defined at an early stage for a smooth Therapeutic Drug Monitoring & Clinical Data Management execution.

INCROE offers services for management and execution of Therapeutic Drug Monitoring & Clinical Data Management from single-center to multi-centric studies in a variety of therapeutic areas.

  INCROE provides a wide variety of Post-Marketing Surveillance services that help sponsors in collecting, comparing, processing, tracking, and reporting possible adverse events to determine the safety of products. Generally, post-marketing surveillance is done in Phase IV of the clinical trial.

• Call Centre services to sort and compile adverse event data
• Literature search
• Data processing and reporting to regulatory authorities
• Periodic Safety Update Reports (Preparation of PSURs)
• Preparation of Individual Case Safety Reports (ICSR)