Alchemy Clinical Research Services is a site management organization that supports clinical trials through patient recruitment and working with sites and investigators. They have a team of experienced professionals and work with sponsors on global and domestic trials. Their services include site selection, project management, monitoring, and full site management from initiation through closeout. They have expertise across many therapeutic areas and a network of sites across India.
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Essential documents are those documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
Essential documents serve to demonstrate compliance with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements. These document files may be audited by the sponsor and regulatory authorities to confirm the validity of the clinical research conduct and integrity of the data.
The essential documents for clinical trials are the following: Investigator's Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form.
Essential documents are commonly referred to as regulatory documents. ICH GCP guidance defines essential documents as “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.
The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide audit trail to permit investigation if and when required.
Siro Clinical Research Institute
Siro Clinpharm initiative
www.siroinstitute.com
Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing.
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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
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Essential documents are those documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
Essential documents serve to demonstrate compliance with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements. These document files may be audited by the sponsor and regulatory authorities to confirm the validity of the clinical research conduct and integrity of the data.
The essential documents for clinical trials are the following: Investigator's Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form.
Essential documents are commonly referred to as regulatory documents. ICH GCP guidance defines essential documents as “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.
The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide audit trail to permit investigation if and when required.
Siro Clinical Research Institute
Siro Clinpharm initiative
www.siroinstitute.com
Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing.
#Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS #management #health #comment #pune
#clinicalresearch #medicaldevices #career #opportunity #oncology
#safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing
#clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch # #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #pharmacovigilance #statistics #biostatistician #opportunity #interview #biostatistics #statisticalprogramming #team #fresher #project #students #development #projects #work #leaders #people #learning #culture #productivity #leader #event #clinicalresearch #clinicaloperations #clinicaldatamanagement #cdm
#clinicalresearchassociate #clinicalresearchcoordinator #pharmacovigilance ,#medicalcoders ,#sas ,#SASprogrammers #Biosatisticians, #Clinicaltrialdesign, #eTMF #lifescience
#medicaldevices,#scdmindia,#societyforclinicaldata
#lifesciencemanagement,#pharmaceuticals,#medicalwriting
#clinicalresearchinstitute #CRA #CRC #Databasedesign
#pharmacovigilanceindia #CTA #pharmacist #EDC , #GCP #pharmacovigilance #clinicalresearch #quality #clinicalresearchassociate #clinicalresearchcoordinator #clinicalresearchjobs #clinicaltrialmanagement #clinicaltrials #clinicaltraining #pharm
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
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
This PPT is explanation about the concept of distant course of clinical rese...RidhimaPatel2
This PPT is explanation about the concept of distant course of clinical research and and the best choice to get distant clinical research course training institute
2. www.alchemyclinical.in
Who We Are ?
• Alchemy Clinical Research Services, is a Site Management
Organization (SMO) with team of experienced professionals who
are highly process-driven in performing global clinical trials.
• Our sole objective is to support the desired outcome of clinical
trials through expeditious enrollment of appropriate patient
population in a sustained and globally acceptable manner.
• As a Site Management Organization we are committed to providing
the highest quality service to our clients, our patients and
physicians. Alchemy's philosophy is that "higher standards and
ethical practices produce a superior product". Our work today
builds hope for tomorrow’s generation.
3. www.alchemyclinical.in
Our Team
• Highly experienced and receptive team
• 5 to 10 years experience in the Pharmaceutical
industry
• Well trained and potential staff (ICH-GCP, ICMR,
Schedule-Y and FDA regulations)
• Experience with all phases of clinical trials (Phase II -
IV) across multiple therapeutic areas, in both paper
and EDC environments
• Immaculate track record for delivery on time and
with quality
4. www.alchemyclinical.in
Our Strengths
• Manage Global as well as domestic clinical trials with precision and
perfection.
• Having Comprehensive project management team, quality expert
management team and potential site coordinators
• Timely execution of sponsors/CRO requirements
• Potential Investigators and sites
• Faster Patient Recruitment
• Maintaining quality of the data
• Resolving and responding to all the queries within timelines
• Strict compliance with study timelines and protocol
• Work with a variety of sponsor’s compounds
• Effective communication
• Compliance with FDA, local regulatory and ICH-GCP guidelines.
5. www.alchemyclinical.in
WHY ALCHEMY
• We present qualified, pre-screened, Principal
Investigators for participation in clinical trials in virtually
any specialty area.
• We ensure timely and accurate regulatory board
submission and data collection
• We provide access to a large patient study population
• We provide ongoing and effective communication
between Sites, Investigators, and Customers
7. www.alchemyclinical.in
Our Services
• We offer a broad range of specialized services to assist
pharmaceutical, biotechnology and medical device companies to
bring new drugs and devices to the market faster.
We offer:
1. Site Selection and Site Feasibility
2. Project Management
3. Site Initiation to Close out Services
4. Monitoring
5. Safety management
• We have a good experience in the complete process - site
evaluation, site initiation, site management and finally site closeout
– so we can ensure prompt response at every stage of the study.
8. www.alchemyclinical.in
Our Site Management Services
Alchemy coordinates with Sites to organize, conduct and
complete successful clinical trials.
Our services include:
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)
9. www.alchemyclinical.in
Our Site Management Services
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
10. www.alchemyclinical.in
C) Pre Close out and Post Close out
• Preparation for site Close out visit
• Archiving of site results and documents
• Preparation and maintenance of quality in case of
management of clinical trials data and medications at
hospital or institute level is one of the best service
provided by us.
Our Site Management Services
11. www.alchemyclinical.in
Therapeutic Areas Expertise
• Alchemy’s operational owes expertise to conduct clinical
trials for both new drugs and medical devices. Our team
has combined experience in the following therapeutic
areas.
• Our primary therapeutic areas are included in the list
below. However, We do have a database for investigators
in nearly all major therapeutic areas. If you have
questions or need for a therapeutic area not listed below,
please contact our Investigator services Department for
more information.
Cntd…
12. www.alchemyclinical.in
• Major Areas
– Cardiology
– Ophthalmology
– Gastroenterology
– Pulmonary & Respiratory Diseases
– Oncology
– Diabetology
– Gynecology
– Neurology
Therapeutic Areas Expertise
13. www.alchemyclinical.in
• Minor Areas
– Dermatology
– Psychiatry
– Pain Management
– Pediatric
– ENT
– Urology
– Renal Disorders
– Rheumatology
Therapeutic Areas Expertise
15. www.alchemyclinical.in
Our Site Network
• We have wide network of Clinical research Sites across
the country well equipped with CRC and Infrastructure.
• Some Major regions:
Maharashtra
Nagpur
Wardha
Amravati
Nanded
Kolhapur
Pune
Chattisgarh
Raipur
Bilaspur
Bhilai
Madhypradesh
Bhopal
Indore
Chindwada
Other sites at:
Karnataka
Andhra
Tamilnadu
Gujarat
Delhi
Uttar Pradesh