|
Considering the diversity of our country and India's unique regulatory and demographic environment, Max Neeman International can help you to achieve your vision with its mission of providing quality delivery of service to both external and internal customers.
Max Neeman International – with its presence across 22 cities in India and with 6 operational offices from Delhi, Mumbai, Chennai, Hyderabad Bangalore and Pune – has access to:
· Good number of ICH-GCP trained Investigators
· Great institution to conduct clinical trials –both Public & Private
· Huge patient load
· Patient Data base
REASONS OF DOING RESCUE TRIALS WITH US:
Fast Rescue Study Start-up
¨ A new initiative of the Indian regulatory authority makes it possible to start your study in India within 4-6 weeks. This directive applies to any study that is currently approved and under way in the United States, the European Union, Japan, or another major country.
¨ Trained and experienced Regulatory team – to get regulatory approval within the shortest possible time.
Access to a Large Pool of Patients
¨ With a population exceeding 1 billion people and a well developed healthcare infrastructure, India has plenty of patients in virtually all therapeutic areas and indications.
¨ In particular, India has a high prevalence of diabetes, cardiovascular disease, hepatitis, cancer, CNS indications, and infectious diseases.
¨ For most diseases the standard of care is inline with the Western countries, including the same diagnostic tools and drugs
¨ Our study team with its presence across India – provides an ideal platform for rescue study – high patient enrollment within the shortest timelines
¨ Access to hospital database – helps to enroll patients for chronic diseases.
¨ More than 90% team members from Max Neeman are M.D.s – help to understand the science of clinical trials and helps to ensure more than 98% patient retention rate.
FDA-Quality Data
¨ Since 2001, Max Neeman CR has managed more than 106 Phase I-IV clinical trials for international companies ranging from small Biotech to large Pharmaceutical industry.
¨ More than 50 of these clinical trials contributed Indian data to FDA submissions.
¨ In many of them our research coordinators provided the recruitment boost required to complete the study.
Unique Strategy
¨ Our experience with clinical trials combined with our unique clinical, data and technology skills allows us to provide innovative solutions for projects.
¨ From project onset, we focuses on the final project goal and identifies potential data, site and protocol issues.
· Address challenges early on and allocate resources strategically to ensure project completion, on-time and on-budget.
· If a project requires an initial needs assessment, our skilled staff will work with the client to identify issues or problems and develop cost-effective, strategic solutions.
WHAT WE CAN OFFER FOR RESCUE STUDIES:-
1. List of more than 30 tertiary care hospitals in different therapeutic areas with:
a. Investigator details including experience in Clinical trials.
b. Infrastructure facilities availability at sites
c. Details of training and experience of Investigators and team.
d. Ethics committee timelines.
2. Patient load in different indications
a. Patient load – both In patient and OPD.
b. Patient data base.
c. Patient load – treatment naïve group.
3. Experience team for each therapeutic areas:
a. We constitute a dedicated experience team for each rescue study.
b. Project lead by a project manager with experience in the therapeutic area.
c. All project team members allocated for the study –are with therapeutic area specific experience.
d. Dedicated research coordinators allotted to sites from pre-study to study completion to ensure enrolment and to ensure 100% retention.
e. Definite project plan in place prior to study initiation.
We have experiences in different rescue projects and have capability to undertake rescue trials in different therapeutic area.
|
