Actimus Biosciences Pvt Ltd is a clinical research organization founded in 2005 in Visakhapatnam, India. It is led by Chairman and Managing Director Ramnath Reddy, who has experience in the healthcare and pharmaceutical industries. The company has facilities for clinical trials including two clinics with 72 beds and laboratories equipped for bioanalytical work. It provides clinical trial services and has experience conducting over 350 studies.
2. Founded By Ramnath Reddy Chairman and Managing Director B.S (Chemical Engineering), M.S. (Biomedical Engineering) University of Massachusetts, Boston, MA. Research Fellow at the Department of Molecular Pharmacology, Physiology & Biotechnology (MPPB), Brown University, Providence, RI. Ramnath Reddy brings his vast experience in the field of Healthcare, pharmaceutical and medical industries to Actimus Bio. He previously worked in several senior management roles like Global Head, Business Development for top five CROs in the Drug Discovery and Development, He is on the board of various companies involved in the Life Sciences field both in India and United States 07/24/10 www.actimusbio.com
4. Actimus Bio Snapshots Incorporated at Visakhapatnam in 2005 Approved by Drugs Controller General of India (DCGI) Registered as 100 % EOU with Visakhapatnam Special Economic Zone (VSEZ) Professionally Managed Private Limited Company Occupied Area : 25,000 Sq. Ft Facility Executed More than 350 Studies 07/24/10 www.actimusbio.com
5. Facilities Two Independent Clinics (72 Beds) with Modern Amenities Fully Equipped ICU Axsym Serology & EM 360 Biochemical Analysers Two API 3200 LC-MS/MS Deep Freezers (-40 & -80属C) and Temperature Controlled Centrifuges Data Back-up Devices Micro Balances (Semi & Ultra) Millipore Units for HPLC Grade water Latest WinNonlin 5.2 & SAS 9.2 Software's and Archival 07/24/10 www.actimusbio.com
6. Value System Actimus Bio takes pride in being Rapid, Responsive and Reliable: Rapid in taking Projects through from Initiation to the Final Report Responsive in Feeding Back to Clients on the progress of their Projects Reliable in the Quality of our work. 07/24/10 www.actimusbio.com
7. Quality System We are concerned about your outcomes.. 5000 + Strong volunteer database Lesser Metabolic Variation In Visakhapatnam we are the only CRO operating so that Quality Volunteers Recruitment is Possible 07/24/10 www.actimusbio.com
8. Services Offering Actimus Bio offers an extensive range of Clinical services including Study Design Project Management Medical Safety Monitoring Biostatistics Quality Assurance Auditing Regulatory Submissions and Scientific Communications 07/24/10 www.actimusbio.com
9. Department Overview Operating with Clinical Research Department Bioanalytical Department Quality Assurance Department Pka and Statistical Department Diagnostic Unit Technical Support Department Finance Department H R and Administrative Department Business Development Department 07/24/10 www.actimusbio.com
10. Regulatory Compliance All Equipments are 21 CFR PART 11 Compliant Laboratory SOPs Complaint with USFDA, ANVISA, ICH Guidelines Strict Adherence to cGLP & cGCP UPS Backup for Un-Interrupted Operation Periodic Calibration (In-house & External) Periodic Preventive Maintenance Check (Through Vendors) Electronic Back-Up of DATA (Project Specific) and Proper Waste Disposal (Contract Vendor) 07/24/10 www.actimusbio.com
11. Project Timeline 07/24/10 www.actimusbio.com Document Development & Internal Approvals 2 Working Days Sponsor Review & Approval 2 Working Days IRB Submissions & Approval 3 Working Days DCGI Submissions & Approval 28 Working Days Project Initiation Approved Protocol 35-40 Days
12. IPR Protection Management of IP Philosophy We value clients IP and Ensure its best protection IP Solely belongs to client Systems and Measures Manual and electronic security in the premises Separate team for each client Employee confidentiality Agreement/Release policy & Stringent CDA Specified NON DISCLOSURE period after release Continuous employee training on confidentiality SOP to handle IP Coding of all project related documents 07/24/10 www.actimusbio.com
13. Partnering with Actimus Bio 5000+ Volunteer Data Base which is top most positive for Actimus Bio being only CRO in Vizag Fastest Take-off time with the best clinical practices Young Team with right competencies & an Excellent Experience Trust-worthy Confidential Standards Effective Functioning of IRB Adherence to SOPs & Protocols Reliable Subject Safety & Internal Processes Committed Proprietary Data Protection 07/24/10 www.actimusbio.com
14. Meeting Clients Requirement Actimus ensures compliance at every level 72 Bed Facility for Conducting both Pilot and Pivotal Studies Provide Efficient Project Management Services Time Management for Robust Delivery Strategic Management & Project Planning Continuous Communication till Project Completion Maximising Resource Flexibility Gathers Population on a Case-by-Case basis Volunteer Database Management Comprehensive Bio-safety Program to Ensure Safety of Volunteers Dietician for providing Study Specific Diet 07/24/10 www.actimusbio.com
16. Contact Us Mr. Y.K.Naidu General Manager Mobile : +91 96760 00400 Email : [email_address] Mr. Ningappa Vathare Executive Business Development Mobile : +918008222278 Email : [email_address] 07/24/10 www.actimusbio.com