Bioclinical Research
Bio-clinical Research caters to the global bio-pharma industry for services in clinical research ( Phase I to Phase IV and BA/BE studies ), medical writing ( scientific and regulatory writing ), clinical data management, and regulatory affairs.
The department has a state-of-the-art-facility with intellectual atmosphere for conducting clinical studies complying to ICH-GCP, National and International regulatory standards. Associates of bio-clinical research department are well trained, experienced and highly competent professionals capable of conducting and handling challenging clinical studies.
EXPERTISE
- Rich experience in conducting several clinical studies with complex study designs and molecules requiring special care of study participants
- Strategies for early/late clinical drug development and formulation development
- Extensively experienced team in handling national and international regulatory inspections
- Effective project management with strict adherence to quality and timelines in conducting clinical studies
- Panel of well-experienced consultants and medical specialists for patient-based clinical studies
CAPABILITIES
Bio-availability/ Bio-equivalence studies
- Fasting and Fed Studies, Open and Blinded studies
- Healthy volunteer and Patient-PK studies
- Single and Multiple dose studies, Dose proportionate studies
- Drug-drug and Food-drug interaction studies
- Post-menopausal studies
- Pharmacodynamic endpoint bio-equivalence studies
- Controlled drug substance studies
Phase I studies
- First-in-Human, Healthy volunteer and Patient based studies
- Proof of Concept, Drug Interaction, PK/PD and Exploratory studies
- Collaboration with several tertiary care hospitals/facilities especially for studies with biosimilars/large molecules
Phase II to IV Studies
- Experienced in handling clinical studies of various therapeutic conditions and studies with small molecules, large molecules/biologicals and medical devices
- Multi-centric national and global clinical trials
- Clinical trial monitoring (onsite and remote)for progress onrecruitment of study participants to ensure effective management of trials and early identification of any potential risks
Medical Writing
- Experienced and trained medical writers working in close collaboration with subject matter experts, advisory team and medical consultants
- High quality regulatory writing (protocol, ICD, CRF, Investigator brochure, Prescribing information, clinical study reports, etc.) and scientific writing (manuscripts, review articles, case reports, abstracts, medical information and marketing materials, white papers, slide decks, posters etc.) services.
- Web-based document management system.
Regulatory Affairs Services
- Strategies and support for variety of regulatory submissions in accomplishing quicker regulatory approvals and authorizations
- Development and compilation of regulatory dossiers (eCTD, Non-clinical and Clinical overviews and summaries) complying with country specific regulatory requirements
Clinical Data Management
- Well established centralized data management services in compliance to all country regulators.
- Global experience in handling clinical trials data for both paper-based and EDC trials
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INFRASTRUCTURE
- Four Independent Clinics totalling 100 beds capacity
- Dedicated 8 bedded fully equipped and functional central ICU to handle medical emergencies
- Walk-in humidity chamber (7,000 liters capacity) to store the investigational products in restricted access and well-defined spacious pharmacy
- Dedicated volunteer registration and screening areas with common volunteer database and software for registration and screening
- Deep Freezers (-80°C) and refrigerated centrifuges
- Dedicated emergency elevator for study participants
- Adequate space for dosing, sample collections and sample processing
- Dedicated volunteer/subject dining and recreational spaces
Reach us
+91 40 67927777
info@admerus.com
#480, Admerus Drive, Basuragadi, Hyderabad, India
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