AILEEN Clinical Research Services
Your guiding light for advancing medical knowledge through groundbreaking research
About Us
Values
Way to Go
Values
A commitment to:
- deliver quality;
- integrity and honesty in all that we do;
- be ethical;
- excel;
- respect people, culture, and partnership;
- share knowledge with our partners, customers and community;
- gain trust;
- deliver what is promised with honesty;
- protect the privacy of patient information and confidentiality of data; and
- be a team worker
Dream
Way to Go
Values
To be a high quality and cost-effective contract clinical research service provider to biopharmaceutical, vaccine, cosmetic and medical device research organisations, and academicians in bringing their innovative therapies and products to the market for public good.
Way to Go
Way to Go
Way to Go
Pool the strength of our expertise, experience, humility, and enthusiasm along with innovator's passion in bringing their innovative therapies and products for public good.
Organisation
Why AILEEN
Economic downturn and quest to increase efficiency, cost savings, greater access to diverse study populations, and experienced personnel with thorough understanding of clinical development.
AILEEN, a Limited Liability Partnership company registered in August 2016, based out of Hyderabad, India advises entrepreneurs on complex clinical evaluation of medical devices, pharmaceuticals, biological, prophylactic vaccines, and cosmetics.
AILEEN can help you transform your innovation into a commercial reality through regulatory support, project management, clinical operations, medical writing, medical affairs, auditing, and training. Data management and statistics is provided through third-party vendors with our complete oversight.
AILEEN is recognised as a "STARTUP" by the Department of Industrial Policy and Promotion, Ministry of Commerce and Industry, Government of India (DIPP37998); as a MICRO Enterprise by the Ministry of Micro, Small & Medium Enterprise (UAM # TS02D0065469); with GST number 36ABGFA0107K1ZS.
How We Help
Passionate experts with an extensive experience in executing and managing clinical trials and academic clinical studies covering most of the therapeutic areas and investigational products, including pharmaceuticals, prophylactic vaccines, and medical devices.
Experience the Difference
We adapt our human resources and processes to address client's demands, offering an efficient service by optimising the quality and cost-efficiency ratio.
Services
Project Management
Medical/ Scientific Writing
Project Management
Project management is critical to ensure that clinical trials are set up, enrolled, performed, and reported on-time and within-budget. We have the required expertise in building the scope, evaluate the timelines, cost, quality, risk management, communications, and stakeholder management, among other areas.
Regulatory Affairs
Medical/ Scientific Writing
Project Management
Online submission of Regulatory Dossier for Test License, Manufacturing License, Application for Conduct of Clinical Trial/ Investigation/ Clinical Performance, Registration and Import of Medical Device/ Investigational Product as per CDSCO requirements.
Medical/ Scientific Writing
Medical/ Scientific Writing
Medical/ Scientific Writing
Clinical Investigation Plan/ Clinical Study Protocol, IB, CRF, ICD and other study-related documents
Paper Case Report Form
Clinical Evaluation/ Study Report
Manuscripts and submission to scientific journals
Clinical Operations
Medical Monitoring and Safety Reporting
Medical/ Scientific Writing
Site/Investigator Identification/ Assessment
Study/Site Initiation
Periodic Monitoring
Study/ Site Close-out
GCP Audit
Medical Monitoring and Safety Reporting
Medical Monitoring and Safety Reporting
Medical Monitoring and Safety Reporting
Medical expertise and oversight for the entire clinical trial, from initial study design through final study close-out
Ensuring clinical integrity of the trial subjects and provide safety accountability across the duration of the study, while acting as expert point of reference for both investigative sites and study team members.
Training
Medical Monitoring and Safety Reporting
Medical Monitoring and Safety Reporting
Regulations for Pharmaceuticals and Medical Devices
CDSCO/ ICH-E6 (GCP)
ICMR National Ethical Guidelines for Biomedical & Health Research
Clinical Research for students
Founders
Sudhakar Bangera
Sudhakar Bangera
Sudhakar Bangera
Dr. Bangera, MBBS, MD, MMedSc (Clinical Trials) and Fellow in Vaccinology (India and International) is the Founder and Managing Partner at AILEEN. Dr. Bangera has an extensive work experience of 30+ years in healthcare (Hospitals and Medical Schools), of which 27 years are in global and local Contract Clinical Research Organisations, Site Management Organisation, Medical Imaging, Clinical Bioavailability and Bioequivalence, global Pharmaceutical and Vaccine-manufacturing companies, and Government organisation (Ministry of Science & Technology) with significant management and leadership experience. He has demonstrated and proven track record for starting and managing businesses including setting up Indian subsidiary of global CRO, administration, and coordination of several hundred complex global programs (clinical studies) in various capacities including top 10 global and local biopharmaceutical companies. Held top managerial positions as COO, Vice-President, Director, Project Manager and Professor in national and international organisations and institutions. Currently, Dr. Bangera is an active mentor for medical technology device startup entrepreneurs at Centre for Cellular and Molecular Platforms, Bengaluru; Atal Incubation Center at CCMB, Hyderabad; IKP, SIIC-IITK, IIT-Bombay, FITT-IITD, Nexus StartupHub, MNR FRI, Global Thinkers Forum and other Bioincubators.
Latha M. S.
Sudhakar Bangera
Sudhakar Bangera
Dr. Latha, MBBS, MD (Pharmacology) is Co-Founder and Partner at AILEEN. Dr. Latha has an extensive work experience of 26 years in healthcare (Hospitals and Medical Schools), Contract Clinical Research Organisation and Pharmaceutical company, strong academic qualifications and significant management experience. She has extensive clinical research experience since 2002 in clinical project management, medical and clinical monitoring, and scientific and medical writing.
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