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Alchemy Clinical Research
 

Alchemy Clinical Research

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Service Overview ...

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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    Alchemy Clinical Research Alchemy Clinical Research Document Transcript

    •                                                       Website: www.alchemyinstitute.in, E-mail: info@alchemyinstitute.in
    •     2  THE ALCHEMY INSTITUTE is a unique institute one of its kind, where tradition and science go hand in hand. THE ALCHEMY INSTITUTE is a unit of The Alchemy Educare Pvt. Ltd. Here at THE ALCHEMY INSTITUTE you will be served the beautiful knowledge of eternal science blended with the technology of modern era. THE ALCHEMY INSTITUTE is a clinical research organization engaged in providing Learning, Consultancy, Research and Analytics services to CROs, Pharmaceutical and Biotechnology companies. THE ALCHEMY INSTITUTE’s areas of competence - Phase II-IV trials, Site Monitoring, Bioanalytical, Auditing for GLP/ GCP compliance, Clinical Data Management and Training services in pharmaceutical and clinical research domain. »Vision • Recognizing the need for skilled man power in the exponentially growing clinical research and allied service industries, our tailor made training course include both hands on and classroom based instructions and are customized to the individual needs of each client. Our aim is to create industry ready, hour one, day one: productive skilled manpower for pharmaceutical research industry. • To be a premier, world-class center for higher education and research in . » Mission THE ALCHEMY INSTITUTE’s mission is to improve health and quality of life by collaborating with academic and industry partners to conduct high quality clinical research in a professionally nurturing and world-class academic environment. • To provide postgraduate education. • To carry out research and development in various domains of science and engineering. • To create centers of excellence to foster cutting edge research. • To provide training to professionals through continuing education programs. • Institute is an independent educational and consulting organization whose mission is the study of the new trends and process issues to improve the access of the world to India for conducting clinical trials.                                                           ABOUTTHEALCHEMYINSTITUTE
    •     3                                                            India is today poised as one of the favorable destination for conducting global clinical trials due to the availability of large patient populations, skilled manpower, cost effectiveness, favorable economic & IP environment etc. Clinical research is a highly specialized field that requires specific training to carry out various job functions. The need and complexity of the specific training at the level of CRA(s)/Monitor(s)/QA Auditor(s) increases as they move up the professional ladder thereby shifting the focus from ‘trouble shooting’ to ‘planning & forecasting’. Increasing disease awareness and research to find newer & novel solutions to the maladies experienced by the mankind has opened up wide vistas for a relatively new field in the healthcare management Industry Clinical Research. Clinical Research Organizations (CROs) which have been active internationally are now making a beeline towards India which offers a wide & varied genetic pool along with skilled professionals. The fast expanding operations of CROs has given rise to a huge demand for bio- science graduates with an understanding about the industry and its operations. THE ALCHEMY INSTITUTE is aimed at imparting basic to advance level skills on various clinical research topics (such as Drug development & clinical trial process, GCP guidelines, Clinical trial monitoring, Drug regulatory affairs etc.) in order to train & develop clinical research professionals by imparting quality education to them. INDIANSCENARIO CLINICAL RESEARCH:
    •     4  SERVICES THE ALCHEMY INSTITUTE offers wide range services for phase II - IV clinical studies across a wide range of therapeutic areas to sponsors having a progressive drug development agenda, so that they can utilize the facilities available in India to achieve their goals in a cost effective and efficient manner. Our range of services for pharmaceutical companies is the following: CONSULTING   We provide consulting services to address individual business needs. THE ALCHEMY INSTITUTE provides the following consulting services to help businesses grow and attain a competitive edge in the market. THE ALCHEMY INSTITUTE will help you with • Setting up of IRB/IEC with all documentation viz, Sop’s, CV’s of the Members, Forms and Letters of approvals, Meeting Schedules etc.. • Setting up of BA/BE facilities and Phase I units • SOP development services • Setting up of GLP laboratories • Strategic planning • Business plan development • Custom research design & implementation Phase II – IV Clinical Research services    We provide the following Clinical Research services: Pre Study Services: • Protocol, ICD and Trial Documents preparation • CRF designing and finalization • SOP’s • Regulatory Approvals • Assistance with EC Dossier and Approval • Randomization Services Study Conduct Services: • Site assessment and feasibility • Site monitoring • Development of monitoring plan • Project Management which includes project compliance to ICH/GCP standards • Investigator site training • Investigator meetings and payments • Quality Assurance • Clinical data management • Statistical services • Clinical study report preparation and finalization Post Study Services: • Study close out • Query Resolution • Site follow up       SERVICES
    •     5      ANALYTICAL  THE ALCHEMY INSTITUTE offers a wide range of solutions to the client's data processing, analysis and management requirements for different kinds of clinical trials. Our experts can support your clinical development needs from CRF designing up to processing, coding, statistical analysis & report writing. Clinical Data Management Services • Database study design and study set up • CRF Designing and Annotation • Data Capture • EDC • Paper CRFs • Data Management Plan • Data Entry & Validation Procedures • Double Data Entry • Medical Coding • Query Management • SAE Management • External Data Load • CDISC Compliant Data Transfer • Database lock and close out • Data Extracts • Data Archival • Statistical Analysis Plan development • Statistical Analysis Medical writing We offer Medical Writing as stand-alone or as part of our other services. Our Medical writing deliverables include: • Clinical Trial protocols • Clinical study reports • Investigator's brochures • Expert reports • New drug applications • FDA briefing documents • Periodic and annual safety update reports • Manuscripts • Abstracts • Posters • Product labeling • Regulatory reports and submissions • Marketing materials • White papers • Training Materials SERVICES
    •     6  SITE MONITORING SERVICES  THE ALCHEMY INSTITUTE offers clinical monitoring services for clinical trials and BA/BE studies. We have a team of monitors headed by a Project Manager & our monitoring services are governed by well defined SOPs and monitoring plans for each study. THE ALCHEMY INSTITUTE has already monitored more than 80+ studies for submission to various Regulatory authorities like US FDA, EMEA, and Health Canada etc. Monitoring services for clinical trials include: • Site assessment and feasibility • Key personnel training • Planning investigator meeting • Site qualification & initiation • Development of monitoring plan • Preparation of interim and final monitoring visit report • Site close out • Closing monitoring report with sponsor BA/BE Monitoring Services: • Clinical monitoring of the Study • Bioanalytical Monitoring – for MD/MV phase Our Team: • Pool of 06 monitors + 01 Project Manager • Team members trained on GCP • Involved in monitoring an large multicentric trial in India We also provide trained resources to be placed at investigator sites for the conduct & for the entire duration of the clinical trial. Auditing Services: • Investigator/Study Site Audit • CRO Audits • IRB Audits • Data and Report Audits etc.                                                           SERVICES
    •     7        HERBAL RESEARCH  “Bridging the gap between traditional system of medicine and modern research ” Herbal  medicines  are  widely  used  in  health‐care  in  both  developed  and  developing  countries.  However,  in  recent  years,  there  have  been  several  high‐profile herbal safety concerns that have had an impact on the public  health, and there is increasing recognition of the need to develop systems  to prove efficacy and safety of herbal medicines.    There  has  been  a  serious  effort  from  the  regulatory  authorities  and  Ayurvedic  Pharmacies  to  test  ayurvedic  treatment  leads  in  early  animal  and human trials.    Clinical trials for herbal medicines are, in many respects, in its infancy and  medicines present unique challenges.    Alchemy, with its unique team of experts from both herbal medicines and  clinical trials, understands this better than any and will help bridging the  gaps between Ayurveda and the modern clinical methods.  HERBALRESEARCH
    •     8  HERBAL RESEARCH SERVES AT ALCHEMY  Medical Writing Medical writing encompasses communicating clinical as well as scientific data and information to different range of audiences in a simple and reproducible format. Our team of expertise combines their core knowledge of science and research skills with thorough understanding of how to represent the derived information and pitch it at the correct frequency for the intended audience. Word processing skills along with good attention to details facilitate comfortable communication of study objectives and outcomes thereby providing sponsors to fasten the regulatory submissions and approvals. We offer the following services: • Protocol Designing • Case report form designing (Both eCRF and Paper CRF) • Informed consent form designing • Informed consent form translation and back translation • Investigator Brochure preparation • Logs for tracking various aspects of the trial • Publication writing • Clinical Study Report Clinical Data Management The data generated during a clinical study has to be managed properly and in a timely manner to derive and interpret the outcomes of the same. A well organized CDM ensures the efficiency of a clinical study process to an entirely new height. Alchemy provide centralized data management services that assists investigators and sponsors in managing protocols, subjects and research data. Our services include: • Data entry • Data Analysis • Data cleaning • Statistical service Pre-Clinical Studies Alchemy is capable of supporting a wide range of GLP and non-GLP toxicology Safety, Efficacy assessment studies. Together with our network of affiliates and our expertise, we offer you a risks free drug development process by conducting quality assured pre-clinical trial. Our on-site Quality Assurance Unit oversees and ensures compliance with all GLP regulations, providing reliable and timely turn-around of final reports. We offer the following services: • Acute toxicity studies • Chronic toxicity Studies • Subchronic Toxicity studies • Efficacy studies in Animals HERBALRESEARCH
    •     9  REGULATORY AFFAIRS   Our regulatory experts have a thorough understanding of local & international regulatory processes, monitoring developments and implementing changes as required. Dossiers that we prepare on your behalf are tailored to the specific requirements of the regulatory authorities with most effective strategy for timely submission and early approval. We support sponsors in: • Dossier preparation and submission for regulatory agencies • Dossier preparation and submission for Independent Ethics Committee and Institutional Review Board Clinical Trial Management Alchemy ensures that all Clinical studies / trials are done as per the SOPs in accordance with ICH GCP guidelines and all other applicable local regulations. Alchemy offers high quality services to manage a Herbal trial on time and on budget. Our experienced Clinical monitoring team monitors, manage and implement quality clinical trial to provide a high end results to the Herbal, Phytochemical & Neutraceutical companies. We offer the following services: • Site feasibility • Site Monitoring • Site selection • Documentation of the trial • Site staff training • Trial site management • Site Initiation • Internal Auditing Formulation Development Alchemy provides consultancy services for formulating novel mono herbal formulations and compounds. Alchemy is committed to providing customized solutions clients in Ayurvedic, phytopharmaceutical and neutraceuticals sectors through processes, methods and services which are compliant to international standards. Our formulation team will identify unique and proprietary products and processes. This will help our clients to come out with tested new brand and improved processes for existing brand thereby improving the acceptance of the market. Alchemy will facilitate the following services: • Novel formulations with data on improved therapeutic performance • Investigate new therapeutic activity for existing product • Identify sources for better consistency of raw materials and standardization • Identify the appropriate manufacturing units for transfer of technology • To test the safety and efficacy through preclinical and clinical trials • Co-ordinate the regulatory approvals • Scientific literature support for launch HERBALRESEARCH
    •     10  CLINICAL RESEARCH TRAINING   Corporate Training Alchemy offers Corporate Training Services in the area of Clinical Research for the Pharmaceutical, CRO and allied life sciences industries for the working professionals. The main objective of these training programs is to impart knowledge based on the changing environment in pharmaceutical and Clinical Research industry. Alchemy has a dedicated team of professionals having vast experience of conducting several clinical trials, with valuable industry knowledge. All the professionals have extensive experience in their areas of specialization and will provide the participants with in depth subject knowledge during the training sessions. Public Awareness programs Although awareness of clinical trials is increasing, participation rates are not, suggesting other barriers to participation. Alchemy uses various clinical trial education programs to inform referring physicians and potential participants about available trials. In addition, awareness programs are also used to inform potential participants about the role of clinical trials in general. A multidisciplinary approach is practiced that reaches out all medical specialties, as well as non physician healthcare providers, such as nurses, patient navigators, pharmacists, and clinical research assistants. This unique mechanism helps Alchemy to realize an increased practitioner and patient participation TRAINING
    •     11    LEARNING   CORPORATE TRAINING PROGRAMS THE ALCHEMY INSTITUTE offers corporate training services in the areas of clinical research for the Pharmaceutical, Clinical Research and Biotechnology sectors. The main objective of our corporate training programs is to impart knowledge based on the changing environment in the pharmaceutical, clinical research and biotechnology industries. We offer customized onsite training programs in the areas of Basic and Advanced GCP/ GLP/Clinical Monitoring/ Pharmacokinetics/IRB Training/ Validation/ 21 CFR Part 11 etc. Our training programs can be taken up by Clinical Research Professionals/Pharma Industry Professionals/Clinical Research coordinators/Associates, Bioanalytical Scientist, Clinical Data Management professionals, Academicians, Regulatory personnel and Techno commercial personnel. THE ALCHEMY INSTITUTE also undertakes custom made training programs depending on the requirements of the sponsors. We are open to engage in training partnerships with pharmaceutical companies, clinical research organizations and allied industry for a mutual synergistic relationship. ACADEMIC TRAINING PROGRAMS CLINICAL RESEARCH: 1. Post Graduate Diploma in Clinical Research (PGDCR) 2. Post Graduate Diploma in Clinical Data Management (PGDCDM|) 3. Post Graduate Diploma in Pharmacovigilance (PGDPV) 4. Post Graduate Diploma in Medical Writing MANAGEMENT (M.B.A.): 1. Health Care Management 2. Hospital Management 3. Hospital Administration Management 4. Clinical Research Management 5. Clinical Pharmacology Management 6. Pathological Lab Management 7. Ayurveda Pharmacy 8. Ayurvedic Diatetics DIPLOMA: 1. Diploma in Vedic Medicinal Microbiology 2. Diploma in Vedic Microbiology TRAINING
    •     12                    w w w . a l c h e m y i n s t i t u t e . i n CONTACTUS THE ALCHEMY INSTITUTE knows your time is valuable, and that the workflow in your practice cannot be disrupted for too long. Write or Call us today to find out how we can exceed your expectations within your budget! The Alchemy Institute T-6, , Vinayaki Bldg, Opp. Fire Station, Varkhande, Ponda, GOA 403401 Ph: 0832 2311013; Mobile: +91 94230 62463 Email:info@alchemyinstitute.in