About INCROE Clinical Services

CLINICAL TRIAL EXECUTION

INCROE leadership and Team comprise of highly qualified and over 20 years experienced professionals who manage all aspects of Phase II to Phase IV Clinical studies including:

Development of essential clinical trial documents (Protocol, ICD, CRF and Investigator Brochure).
Feasibility of clinical trial studies.
Investigator site selection and management.
Monitoring and audit of clinical trial sites.
Clinical trial material logistics and management.
Decentralized Clinical Trials
Analyzing and preparation of clinical study reports (CSR).
Responding to regulatory agency’s request for information pertaining to product safety.

REGULATORY AFFAIRS

At INCROE, we provide a regulatory affairs consultancy tailored to meet the client’s specific needs. Client’s data security and confidentiality is assured to the highest level.

Our regulatory team has significant global experience in 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 following applications:

Bulk Drugs
Finished Formulations
Medical Devices and IVDs
Vaccines

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

TDM & CLINICAL DATA MANAGEMENT

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.

MEDICAL WRITING & TRANSLATION

INCROE offering all medical writing services from Phase II to IV clinical studies. Our medical writing team comprises of physician 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, Anti-microbiological Agents and Herbal Drugs. Our team have 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 translating services ranging from patient information sheet, Patient Diaries, ICD, CRF, Product Labels, Pharmacology Reports, Toxicology reports, Clinical Study Reports (CSR) and Investigator Brochures. We are providing translation services in 70+ languages.

POST MARKETING SURVEILLANCE

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