Due to our project management and clinical operations heritage, ARIRDMSCRO has been an industry niche services provider start up in consulting. Having such a breadth of experience within our project management, our clinical operations employees allows us to provide our clients the needed expertise for their projects.  From study start up through to the final analysis, from Phase II to submission, our Project management consultants are among the leaders in their respective areas enabling our clients to have the ability to choose expertise from a range of consultants to match their needs and reach their IND submission, publication or research goals.

We offer clinical project management and clinical operations consultancy in areas such as:

Clinical Study Design

An optimally designed trial can reduce costs and save time, either by requiring a smaller sample size or by stopping a trial earlier in time without continued wasted budgets and efforts. Our project management with clinical operations consultancy team have been involved with a broad spectrum of clinical study designs across a wide range of therapeutic areas and can draw upon their experiences to support your clinical development program. We can support with:

• Writing Project Management and Clinical Operations Sections of Complex Protocols including Master Protocols
• Conducting Simulations to Estimate and Optimize Study Sample Size based on Lean & Six sigma principles
• Exploring use of novel niche designs across Drug/Device Development Program
• Support in planning of adaptive trial designs and drug/device clinical development sequential Trials and related stopping rules for interim analyses.
• Maximizing Study Efficiency through Best Project management and clinical operations practices, including project management mythologies.
• Efficient support for Biosimilars
• Specialist Expertise in Pharmacokinetic Analysis and Reporting 

Alternative Trial Types

Our Project Management and Clinical Operations consultants are experienced in handling data and protocol methodologies that lie beyond the standard randomized controlled clinical trial (RCT), our consultants are highly skilled in appropriate use of other data sources including:

• Registry Studies
• Real World Evidence/Data studies (Investigator initiated studies)
• Health Economics and Outcomes Research (HEOR): Due to their observational nature, analyzing these data requires specific methods and an understanding of Observational Studies to ensure the correct conclusions are drawn. Our consultant will be able to plan the correct analytical methods to deal with these data sources and ensure all potential source of bias are identified and properly managed.
• Handling and Prevention of Missing Data

Whether it is missing data in clinical trials due to poor patient engagement or from a lack of data in Observational studies, our project management matrix consulting offers a range of methodologies to handle missing data including:

Analysis of studies data to assess sensitivity (Sensitivity Analyses) of the main results to alternative scenarios (e.g. to assess impact of differential drop-out rates)

 Risk Based Approaches & Regulatory Submissions

With constantly evolving guidance and various opportunities for improved clinical trial efficiency in the recent ICH- GCP, Indian GCP and NDCT, Mar 2019, our consultants understand the demand and practicality of embracing new technologies and methods and offer the following:

Regional based regulatory support including an independent review of submission dossiers
Data Quality Oversight through the creation of Monitoring Reports
Development of protocols and other documents for a risk based approach to monitoring