IICRM offers site management services for phase II - IV clinical studies across a wide range of therapeutic areas to sponsors having a progressive drug development agenda, so that they can utilize the facilities available in India to achieve their goals in a cost effective and efficient manner.
Our range of services for pharmaceutical companies is the following:.

Feasibility Assessment

An accurate feasibility assessment plays a crucial role in identifying and assessing status of the clinical study. We provide assistance in deciding whether to proceed with, alter, or drop a particular project or plan of action.
We have a extreme knowledge of the strengths and weaknesses of the clinical trial process within each site and are well placed to make thorough assessments of the suitability for a particular study. We respond within a week of conducting the assessment. The outstanding results help us in creating trust and confidence within our clients. Give us the opportunity to work for you; we will let you know the challenges, trends and issues to save your time, money and stress.

• Investigator Identification: We can quickly shortlist investigators across a range of parameters including investigator qualification, specializations, clinical trial experience, recruitment records and thus help in placing your study in experienced hands.


• Site Identification: For successful implementation of trial studies it is important to identify proper sites and we help pharmaceutical companies in the identification of potential, ICH-GCP compliant sites

At IICRM, we offer free feasibility assessment. To request your feasibility assessment,
Site Preparation and Up gradation: Our perpetual efforts to upgrade infrastructure at sites is in accordance with the protocol specific requirement making sure they qualify for participating in the trial.

IRB / IEC Submissions We understand the ethics and regulatory environment in India better with our rich experience in handling large number of studies across various centers in India. We work closely with Investigators ensuring one time submission & approval with all subsequent amendments are conveyed and favorable approval obtained. All safety events are reported within the specified timelines with timely reporting on the progress of the study.

Patient Recruitment Using Our Unique FEP Method
When your clinical trial is delayed by slow subject enrollment, you need to quickly identify the issues impacting patient recruitment to find the best solutions. We are dedicated to provide you with excellence in patient recruitment strategies and services to improve outcomes - regardless of the clinical trial obstacles you face.

Documentation with Electronic Data Capture (EDC) expertise
We place a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staffs with all day-to-day study conduct activities. Our coordinators are trained to provide professional support to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of assigned duties. The study coordinators are experienced in Electronic Data Capture (EDC) based trials. This helps in accurate data entry and thereby reducing queries from data management departments. Our Project Management and Quality Management Team carry out constant internal monitoring at the various sites to facilitate the documentation efficiently. This ensures collection of high quality study data necessary for regulatory and product approval submissions.

Monitoring
We have an extended monitoring service that ensures perfect functioning. Our dedicated Monitors visit different hospitals to find out the status of the project. This includes assessing the documentation work, infrastructure setups, patient recruitment status & efforts, functioning, and other aspects of project.

Training
Our HR policy addresses the need to retain the talent and our training program improves the standards of our employees and the investigators. We put strong emphasis on continuous professional development and to that end in-service training across all sites is mandatory for employees. All sites are trained in and adhere to the Standard Operating Procedures (SOPs), IICRM SOPs also cover patient recruitment and retention. To ensure that clinical research is conducted to the highest possible standards, all are trained on Good Clinical Practices (GCP) before conducting their first study at our site.

Consulting & Regulatory Support Services
Our understanding of regulatory environment and experienced personnel, places us at a competitive position to serve our clients better. We are prominent with the ethics and regulatory requirements since we have done large number of studies. We prepare the regulatory package which includes: Investigator CVs, Financial Disclosure Forms (FDFs), Investigator Undertakings, FDA Form1572, IRB Forms, Informed Consent Templates, and Site Contact Information Forms. Developed a software for ECRF ,Regulatory package will then be submitted to the sponsor. The entire process is completed quickly so that rapid review can be done.

Staffing Services
We provide skilled and well experienced human resources to the pharmaceutical companies so that highest possible standards can be maintained. Our project members works for the pharmaceutical companies at daily or monthly basis.

• Essential Principal Investigator training
• Meets IRB requirements and OHRP recommendations
• ICH endorsed for international markets
• Staff & site training in research practices
• Live video feed for site visits & training
• Ongoing training systems and SOPs
• Site readiness & self-assessment audits
• Designed to be low impact on your daily workflow
  

Good Clinical Practice (GCP) training has become an IRB standard
IICRM specializes in educating both experienced and novice Principal Investigators in “Good Clinical Practice.” The reflexive interpretation of “GCP” is that it has something to do with being a good doctor. However, one of the fundamental differences of being a Principal Researcher has to do with your responsibilities towards the research subject. Research subjects are not “patients.” This is just one of the many essential distinctions about which you must demonstrate knowledge to the IRB.

IICRM knows your time is valuable, and that the workflow in your practice cannot be disrupted for too long. That’s why we have designed GCP training that fits your budget and operations. We even have access to the latest technology that can provide a LIVE video feed of training to remote locations. Our experienced team delivers vital insider knowledge efficiently, professionally, and with a wry sense of humor that is all-too-rare in the research world (our research cartoons are famous throughout the industry).

We also offer a unique site readiness and appraisal program that you can perform yourself at one or many research sites, which will give you important insight as to your readiness for an audit. Don’t let your reputation and business practices be crippled by negative inspections!

Call us at 9823402090/9158922736/9860409016 today to find out how we can exceed your expectations within your budget!