Project Management
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Project Management at GVK BIO is led by skilled and highly motivated executives with experience averaging 6-7 years. Our Project Managers (PMs) employ proven planning, time management, problem solving and communication skills to ensure timely project delivery, determined to exceed customer expectations.
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Service Overview
Site management services to CRO and SITE:
A) Pre initiation
Identification of Potential Sites
Faster Feasibility
Site set up, supplies and other infrastructure needs
Regulatory and IEC/ IRB communications
Rapid negotiation of CTA
Setting up Standard Operating Procedures (SOPs)
B) During Study Duration
Provide dedicated trained and experienced CRCs (Clinical research coordinators)
Patient recruitment & retention Support
Maintenance of essential documents
Source documentation as per ALCOA standards (Attributable, Legible, Contemporaneous, Original & Accurate
Regular IP (Investigational Product) accountability and storage
Completion of CRF’s within timelines
Faster query resolution
Reporting of AE, SAEs within timelines
Support Monitoring visits and Quality Assurance audit action items.
Patient visit Follow Up and compliance assistance
Preparation of site for monitoring and audits/ inspections
C) Post Close out
· Archiving of site results and documents
Site Identification
Faster Feasibility
Ready Sites
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Life Sciences recruitment
Whether you are looking for staff in the biotechnology, primary pharmaceutical, secondary pharmaceutical or fine chemicals sectors, we can supply the best talent globally.
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GVK BIO is one of the largest India-based Discovery, Development and Manufacturing solutions provider to the Biopharma industry. GVK BIO provides a continuum of Drug
Discovery solutions from pre-Hit to candidate
selection. Our expertise spans across
numerous therapeutic areas with a focus on
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PK Services
GVK BIO vivarium is AAALAC certified and registered with CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals), Government of India.
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The Medical Affairs team at GVK Biosciences (GVK BIO) comprises of well trained medical professionals with cumulative Clinical Research experience of about 28 years.
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At GVK BIO, seamless integration of life sciences expertise with information technology helps bring database products and services to accelerate your research from discovery to development.
Clinical METadata
This short document appears to contain numerical values, including the numbers 6.1, 20, and 17, but provides no other context or explanation. It is unclear what these numbers represent or what the overall topic or purpose of the document is based on the limited information given.
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GVK Biosciences (GVK BIO) offers screening services for drug discovery to determine biological activity and properties customized to meet the research needs of the Pharma and Biotech industries. Our range of assays include Biochemical, Cellular, ADME assays & Animal models for profiling of NCEs for Potency, Selectivity, Efficacy, Drugability and Toxicity.
BIO IT
BioIT converts information to knowledge for usage in Discovery & Development. It integrates data from multidisciplinary areas using Science and Information Technology
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Project Management
- 1. Project Management Project Management at GVK BIO is led by skilled and highly motivated executives with experience averaging 6-7 years. Our Project Managers (PMs) employ proven planning, time management, problem solving and communication skills to ensure timely project delivery, determined to exceed customer expectations. PMs are supported by Team Leads and Monitors, which assures GCP and regulatory compliance, data integrity and delivery of quality metrics. Our teams strive to promote positive personal relationships with a high level of mutual trust and self-confidence. Collectively, GVK BIO Project Management team has had a vast experience of working with a diverse set of customers across the Pharmaceutical, Biotech and Medical Device industries. Therapeutic Expertise GVK BIO has successfully worked in diverse therapeutic areas with studies that often have had stringent enrollment criteria, and tight timelines for submission to the USFDA, WHO or local regulatory authorities. Therapeutic Expertise Number of Studies (Percent) Oncology (18%) Pain (14%) Infectious Disease (23%) Services Offered • Study Feasibility • Site & Investigator Selection Bone CNS (9%) Diseases (9%) • Site Monitoring • Project Management • Clinical Trial Supply Management • Vendor Management We offer customized services which can be availed on a standalone basis or as part of an integrated full service offering. Regulatory Affairs We have an experienced in-house team that provides consultancy and local regulatory liaison. The team manages submission of the Clinical Trial Application, follows up to obtain approval for conduct of the study and licenses for import/export of the investigational product, submits safety updates, annual status reports and troubleshoots on behalf of the client. In association with our US partners, we are capable of managing submissions to the US FDA for studies to be conducted under a US IND. Study Phases Number of Studies (Percent) Phase I 5% Phase IV 9% Phase II 36% Phase III 50%
- 2. Project Management Training and e-learning Training activities are driven by a Training SOP that mandates regular training of all employees. New employees receive training in three phases: • Mandatory and immediate • Mandatory and extended • Supplemental and refresher Every individual at GVK BIO is aligned to deliver highest value to clients, which is further reinforced by the quality of our Senior Management. Compliance, timeliness and cost consciousness are ingrained in GVK BIO personnel and processes to achieve highest level of client satisfaction. About GVK BIO Training is tracked and assessed through an electronic learning management system. GVK Biosciences (GVK BIO) is Asia’s leading Discovery Research and Development organization. GVK BIO provides a broad spectrum of services, stand-alone and integrated, across the R&D value chain. GVK BIO Presence Services The GVK BIO Clinical Research unit is headquartered in Gurgaon, (Delhi, National Capital Region) with easy access to federal regulatory offices as well as to key investigators and institutions in the north of the country. In addition, a segment of clinical study management and monitoring staff are located regionally in Mumbai, Hyderabad and Chennai to ensure comprehensive coverage of sites along the critical North-West-South axis. Project Managers play a pivotal role through the course of the study, maintaining constant communication with sites, sponsors and regional monitoring staff. Global Footprint Membership in a consortium of CROs allows us to offer global recruitment capabilities across North and South America, Central and Western Europe, Russia, the Middle East, Africa and the Indian subcontinent. Project Management S P O N S O R Biotech Pharma Medical Devices Project Manager Internal Environment Monitoring Team Allied Services CDM / MW / STATS Medical Monitors Support Functions • Chemistry Services • Process R&D and Custom Synthesis • Biology • Informatics • Clinical Research • Clinical Pharmacology Contact: bdcrd@gvkbio.com Visit: www.gvkbio.com