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www.alchemyclinical.in
Research | Training | Consulting
www.alchemyclinical.in
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.
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
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.
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
www.alchemyclinical.in
Consulting Sites &
Investigator
FOR CRO
Corporate
Training
Services
At
Alchemy
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.
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)
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
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
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…
www.alchemyclinical.in
• Major Areas
– Cardiology
– Ophthalmology
– Gastroenterology
– Pulmonary & Respiratory Diseases
– Oncology
– Diabetology
– Gynecology
– Neurology
Therapeutic Areas Expertise
www.alchemyclinical.in
• Minor Areas
– Dermatology
– Psychiatry
– Pain Management
– Pediatric
– ENT
– Urology
– Renal Disorders
– Rheumatology
Therapeutic Areas Expertise
www.alchemyclinical.in
• Special Areas
– Ayurveda
– Herbal Research
– Neutraceuticals
– Cosmetics
– Cosmeceuticals
Therapeutic Areas Expertise
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
www.alchemyclinical.in
Some of Our Clients
www.alchemyclinical.in
• We are happy to work with some reputed CROs & Sponsors
www.alchemyclinical.in
THANK YOU
Alchemy Clinical Research Services
31, PawanBhoomi, Wardha Road,
Nagpur – 440025
Tel: +91 712 6600692
Cell: +91 9423062463 / +91 9960032038
Email: info@alchemyclinical.in / info@alchemyinstitute.in
www.alchemyinstitute.in

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Alchemy SMO

  • 1. www.alchemyclinical.in Research | Training | Consulting www.alchemyclinical.in
  • 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
  • 6. www.alchemyclinical.in Consulting Sites & Investigator FOR CRO Corporate Training Services At Alchemy
  • 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
  • 14. www.alchemyclinical.in • Special Areas – Ayurveda – Herbal Research – Neutraceuticals – Cosmetics – Cosmeceuticals 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
  • 16. www.alchemyclinical.in Some of Our Clients www.alchemyclinical.in • We are happy to work with some reputed CROs & Sponsors
  • 17. www.alchemyclinical.in THANK YOU Alchemy Clinical Research Services 31, PawanBhoomi, Wardha Road, Nagpur – 440025 Tel: +91 712 6600692 Cell: +91 9423062463 / +91 9960032038 Email: info@alchemyclinical.in / info@alchemyinstitute.in www.alchemyinstitute.in