SlideShare a Scribd company logo
1 of 10
Essentials for Setting up a
New Clinical Research Center
Introduction
This one is for all the doctors and medical specialists who are interested in
opening up their own research clinic.
As a doctor who’s interested in this option, we imagine that you’ve already seen a
clinical research environment either by participating as a sub-investigator or a PI
(principal investigator). If this is the case and you’re already familiar with
everything that clinical research entails, then you’re in a good position to start
your own clinical research center or research clinic.
2
First of all, just like any other business, in clinical
research you should also start small and grow
step by step. This means that you can start
clinical research in your own private practice.
After a while, if you see that you’re successful
and everything is going well, you can choose if
you want to enlarge your clinic or open up a new
one.
How to Start?
4
Essentials for Setting Up
a Research Clinic
If you own a private practice with a lot of patients in your database, then
opening your own research clinic is an excellent idea. The essentials for
opening a research clinic can differ based on your budget, so here we’ll
only give you the minimum requirements necessary for the beginning. All
of these requirements are based on conducting 5 to 10 studies a year in
your clinic.
Your Hospital
5
Essentials for Setting Up a Research Clinic
The first and most necessary thing you’ll need is an
exam room for the patients who enroll in the trials.
We are putting this as a separate point because
usually, your regular exam room for all your other
patients isn’t a good fit for the study subjects,
especially if you have a busy clinic. So, having an
extra exam room is a must in this case!
EXAM ROOM
You are probably already sitting in this room! Since
you are going to be the owner of this research
clinic, we suppose that you will be the PI or the
Principal Investigator. If so, then you’ll need an
office for yourself, and this can be the office that
you already use for your private practice.
PI ROOM
Your Hospital
6
Essentials for Setting Up a Research Clinic
Since most of the tasks in a trial are delegated to
coordinators, you will need to provide them with a
coordinators’ office where they can work.
Coordinators are some of the most overworked
people during a trial, so it’s impossible for them to
work without an office. Make sure that the office
you prepare for coordinators is only for them, and
not a common office with monitors coming in for
visits.
COORDINATORS ROOM
Another important office space that you’ll need is
the room for monitors. Always try to make a
separate room only for when monitors come in, so
that you avoid situations when the monitors find
documents or papers they aren’t supposed to. For
example, if a monitor comes for a visit in the middle
of a busy day, the coordinators’ office will usually
be a mess, so if you settle the monitors in the same
office, they can find many more things to complain
about. This is why having a clean monitor-only
room is important for every research clinic or
clinical research center.
MONITORS ROOM
Different rooms for
CRCs and CRAs!!!
Your Hospital
7
Essentials for Setting Up a Research Clinic
If you have the budget for it, try to have a separate
IP room that will be locked, with limited access, no
traffic, and with controlled temperature. In reality,
the minimum requirement is an IP cabinet.
However, placing this cabinet in a room where
unauthorized staff and patients walk through is
risky and can cause you many problems with the
FDA, the sponsor, and the monitors. If you aren’t
able to afford to have a separate IP room, then
make sure to place the IP cabinet somewhere
where patients won’t have access to it. And
remember, the IP cabinet also has to be double
locked and with controlled temperature.
IP ROOM / IP CABINET
Yet another thing you’ll need in your clinic is a
centrifuge and a fridge. These are needed both for
the investigational drug (IP) as well as for blood
and other specimens that will have to be kept and
processed throughout the trial.
CENTRIFUGE AND FRIDGE
Your Hospital
8
Essentials for Setting Up a Research Clinic
A common mistake that many clinics make is
underestimating how much space source and regulatory
documents can take. There are thousands of documents
involved in a single protocol, so make sure that your
research center has enough room to store all these
important documents.
PHYSICAL SPACE FOR
DOCUMENTATION STORAGE
Most clinics will usually need to have a lab where they
can draw blood, process it (once you have a waiver as
a permission), and ship the results. In the past, ECG
machines were usually provided by the sponsor, but
nowadays, it’s expected that sites have their own ECG
machines available for study participants.
LABORATORY AND ECG
Your Hospital
9
Essentials for Setting Up a Research Clinic
As we’ve mentioned many times before, clinical trials
are complex and they require a lot of correspondence
with vendors, patients, staff, sponsor, etc. For this
reason, it’s practically impossible to work without a fax
machine and internet connection. On top of that, most
sites are slowly transferring completely online these
days, in clouds and virtual workspaces, and they start
using EDC systems, CTMS, etc. All of these things are
extremely important, so having a good connection is a
must!
FAX AND INTERNET
Last but not least, you’ll need time! Even though as
a PI you’ll be able to delegate most of your tasks to
other site staff such as coordinators, you’ll still need
to realize that clinical research does require time.
At the beginning, until you get used to everything
and learn things, you can try giving half of your time
to clinical research and the other half to your
private practice. Later on, when things are running
smoothly with the trial, you can probably delegate
more of your responsibilities. Like this, you’ll have
more time to dedicate to your private practice while
still enjoying the benefits of doing research
TIME
www.trialjoin.com
CONCLUSION
Above, we’ve given you 10 things that can serve you as a checklist of the minimum requirements essential for setting up a new clinical
research center. Even though it might seem complicated at the beginning, if you have a busy private practice and a large patient pool
then this is probably the perfect thing for you to do.
Aside from the medical advancements that you’ll be a part of, clinical trials are also lucrative, so the benefits of opening a research clinic
are definitely worth the risks.
10

More Related Content

What's hot

Safety reporting of a clinical trial
Safety reporting of a clinical trialSafety reporting of a clinical trial
Safety reporting of a clinical trialGOURIPRIYA L S
 
Most Common Clinical Research Site Worries and Complaints
Most Common Clinical Research Site Worries and ComplaintsMost Common Clinical Research Site Worries and Complaints
Most Common Clinical Research Site Worries and ComplaintsTrialJoin
 
Archiving of clincial study records.pptx
Archiving of clincial study records.pptxArchiving of clincial study records.pptx
Archiving of clincial study records.pptxRishimaheshwari14
 
Clinical Trials Registry
Clinical Trials RegistryClinical Trials Registry
Clinical Trials Registrybiinoida
 
Clinical trial protocol, ammendments, Protocol deviations and violations
Clinical trial protocol, ammendments, Protocol deviations and violationsClinical trial protocol, ammendments, Protocol deviations and violations
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
 
Case Report Form (CRF) Design Tips
Case Report Form (CRF) Design TipsCase Report Form (CRF) Design Tips
Case Report Form (CRF) Design TipsPerficient
 
Essential document (ich gcp)
Essential document (ich gcp)Essential document (ich gcp)
Essential document (ich gcp)bhunjawa
 
Drug accountability: an important aspect of clinical research
Drug accountability: an important aspect of clinical researchDrug accountability: an important aspect of clinical research
Drug accountability: an important aspect of clinical researchTrialJoin
 
Auditors roles & responsibilities in CT as per ICHGCP
Auditors   roles & responsibilities in CT as per ICHGCPAuditors   roles & responsibilities in CT as per ICHGCP
Auditors roles & responsibilities in CT as per ICHGCPSuhas Reddy C
 
Patient recruitment
Patient recruitmentPatient recruitment
Patient recruitmentswati2084
 
Research support including planning and excution of clinical trails
Research support including planning and excution of clinical trailsResearch support including planning and excution of clinical trails
Research support including planning and excution of clinical trailsPooja Anothra
 
Best strategies for successful recruitment and retention
Best strategies for successful recruitment and retentionBest strategies for successful recruitment and retention
Best strategies for successful recruitment and retentionTrialJoin
 
CLINICAL TRIAL DOCUMENTS
CLINICAL TRIAL DOCUMENTS CLINICAL TRIAL DOCUMENTS
CLINICAL TRIAL DOCUMENTS Rishabh Sharma
 
Adaptive Study Designs
Adaptive Study DesignsAdaptive Study Designs
Adaptive Study DesignsAnirudha Potey
 

What's hot (20)

Safety reporting of a clinical trial
Safety reporting of a clinical trialSafety reporting of a clinical trial
Safety reporting of a clinical trial
 
Most Common Clinical Research Site Worries and Complaints
Most Common Clinical Research Site Worries and ComplaintsMost Common Clinical Research Site Worries and Complaints
Most Common Clinical Research Site Worries and Complaints
 
Archiving of clincial study records.pptx
Archiving of clincial study records.pptxArchiving of clincial study records.pptx
Archiving of clincial study records.pptx
 
Clinical Trials Registry
Clinical Trials RegistryClinical Trials Registry
Clinical Trials Registry
 
Monitoring Visits
Monitoring VisitsMonitoring Visits
Monitoring Visits
 
Schedule Y amendments
Schedule Y amendments Schedule Y amendments
Schedule Y amendments
 
Clinical trial protocol, ammendments, Protocol deviations and violations
Clinical trial protocol, ammendments, Protocol deviations and violationsClinical trial protocol, ammendments, Protocol deviations and violations
Clinical trial protocol, ammendments, Protocol deviations and violations
 
Case Report Form (CRF) Design Tips
Case Report Form (CRF) Design TipsCase Report Form (CRF) Design Tips
Case Report Form (CRF) Design Tips
 
Essential document (ich gcp)
Essential document (ich gcp)Essential document (ich gcp)
Essential document (ich gcp)
 
Drug accountability: an important aspect of clinical research
Drug accountability: an important aspect of clinical researchDrug accountability: an important aspect of clinical research
Drug accountability: an important aspect of clinical research
 
Cra responsebility
Cra responsebilityCra responsebility
Cra responsebility
 
Essential Documents for the Conduct Of a Clinical Trial
Essential Documents for the Conduct Of a  Clinical TrialEssential Documents for the Conduct Of a  Clinical Trial
Essential Documents for the Conduct Of a Clinical Trial
 
Auditors roles & responsibilities in CT as per ICHGCP
Auditors   roles & responsibilities in CT as per ICHGCPAuditors   roles & responsibilities in CT as per ICHGCP
Auditors roles & responsibilities in CT as per ICHGCP
 
Patient recruitment
Patient recruitmentPatient recruitment
Patient recruitment
 
Research support including planning and excution of clinical trails
Research support including planning and excution of clinical trailsResearch support including planning and excution of clinical trails
Research support including planning and excution of clinical trails
 
Best strategies for successful recruitment and retention
Best strategies for successful recruitment and retentionBest strategies for successful recruitment and retention
Best strategies for successful recruitment and retention
 
CLINICAL TRIAL DOCUMENTS
CLINICAL TRIAL DOCUMENTS CLINICAL TRIAL DOCUMENTS
CLINICAL TRIAL DOCUMENTS
 
How to report an SAE
How to report an SAEHow to report an SAE
How to report an SAE
 
Adaptive Study Designs
Adaptive Study DesignsAdaptive Study Designs
Adaptive Study Designs
 
Components of a clinical study protocol
Components of a clinical study protocolComponents of a clinical study protocol
Components of a clinical study protocol
 

Similar to Essentials for Setting up a New Clinical Research Center

Problems that you can solve with clinical rotation scheduling software
Problems that you can solve with clinical rotation scheduling softwareProblems that you can solve with clinical rotation scheduling software
Problems that you can solve with clinical rotation scheduling softwareRotation Manager
 
Empathy and Lean - Quality and Metrics
Empathy and Lean - Quality and MetricsEmpathy and Lean - Quality and Metrics
Empathy and Lean - Quality and MetricsEndeavor Management
 
Patient Recruitment Strategies for Sponsors and CROs
Patient Recruitment Strategies for Sponsors and CROsPatient Recruitment Strategies for Sponsors and CROs
Patient Recruitment Strategies for Sponsors and CROsKunal Sampat
 
Most Common Clinical Research Site Worries and Complaints
Most Common Clinical Research Site Worries and ComplaintsMost Common Clinical Research Site Worries and Complaints
Most Common Clinical Research Site Worries and ComplaintsAnand Butani
 
5 Key Pitfalls to Avoid in the MedTech Clinical Data Collection.pdf
5 Key Pitfalls to Avoid in the MedTech Clinical Data Collection.pdf5 Key Pitfalls to Avoid in the MedTech Clinical Data Collection.pdf
5 Key Pitfalls to Avoid in the MedTech Clinical Data Collection.pdfThe Lifesciences Magazine
 
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docx
 352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx 352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docxaryan532920
 
2. An executive summary that explains your approach and findings (.docx
2. An executive summary that explains your approach and findings (.docx2. An executive summary that explains your approach and findings (.docx
2. An executive summary that explains your approach and findings (.docxfelicidaddinwoodie
 
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docx
352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docxtarifarmarie
 
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docx
 352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx 352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docxShiraPrater50
 
Patient retention challenges and the best ways to solve them
Patient retention challenges and the best ways to solve themPatient retention challenges and the best ways to solve them
Patient retention challenges and the best ways to solve themTrialJoin
 
orthodontic practice management
 orthodontic practice management  orthodontic practice management
orthodontic practice management payal ostwal
 
User Driven Development For Palinet
User Driven Development For PalinetUser Driven Development For Palinet
User Driven Development For PalinetJonathan Clark
 
12 steps to better healthcare
12 steps to better healthcare12 steps to better healthcare
12 steps to better healthcareMark H. Davis
 
How to find investigators for clinical trials
How to find investigators for clinical trialsHow to find investigators for clinical trials
How to find investigators for clinical trialsDan Sfera
 
Michael vassar interview
Michael vassar interviewMichael vassar interview
Michael vassar interviewAri Meisel
 
7 Essential for Doctors intersted in a Career in Health tech
7 Essential for Doctors intersted in a Career in Health tech7 Essential for Doctors intersted in a Career in Health tech
7 Essential for Doctors intersted in a Career in Health techAlvinadcruze
 

Similar to Essentials for Setting up a New Clinical Research Center (20)

Problems that you can solve with clinical rotation scheduling software
Problems that you can solve with clinical rotation scheduling softwareProblems that you can solve with clinical rotation scheduling software
Problems that you can solve with clinical rotation scheduling software
 
Can your Lab compete?
Can your Lab compete? Can your Lab compete?
Can your Lab compete?
 
Empathy and Lean - Quality and Metrics
Empathy and Lean - Quality and MetricsEmpathy and Lean - Quality and Metrics
Empathy and Lean - Quality and Metrics
 
Virtual Medical Scribes
Virtual Medical ScribesVirtual Medical Scribes
Virtual Medical Scribes
 
Patient Recruitment Strategies for Sponsors and CROs
Patient Recruitment Strategies for Sponsors and CROsPatient Recruitment Strategies for Sponsors and CROs
Patient Recruitment Strategies for Sponsors and CROs
 
180 + immune system
180 +  immune system180 +  immune system
180 + immune system
 
Most Common Clinical Research Site Worries and Complaints
Most Common Clinical Research Site Worries and ComplaintsMost Common Clinical Research Site Worries and Complaints
Most Common Clinical Research Site Worries and Complaints
 
5 Key Pitfalls to Avoid in the MedTech Clinical Data Collection.pdf
5 Key Pitfalls to Avoid in the MedTech Clinical Data Collection.pdf5 Key Pitfalls to Avoid in the MedTech Clinical Data Collection.pdf
5 Key Pitfalls to Avoid in the MedTech Clinical Data Collection.pdf
 
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docx
 352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx 352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docx
 
2. An executive summary that explains your approach and findings (.docx
2. An executive summary that explains your approach and findings (.docx2. An executive summary that explains your approach and findings (.docx
2. An executive summary that explains your approach and findings (.docx
 
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docx
352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docx
 
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docx
 352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx 352018 IFSM 305 – Case Study Page  1  Midtown Fami.docx
352018 IFSM 305 – Case Study Page 1 Midtown Fami.docx
 
Patient retention challenges and the best ways to solve them
Patient retention challenges and the best ways to solve themPatient retention challenges and the best ways to solve them
Patient retention challenges and the best ways to solve them
 
orthodontic practice management
 orthodontic practice management  orthodontic practice management
orthodontic practice management
 
User Driven Development For Palinet
User Driven Development For PalinetUser Driven Development For Palinet
User Driven Development For Palinet
 
12 steps to better healthcare
12 steps to better healthcare12 steps to better healthcare
12 steps to better healthcare
 
Strategic plan
Strategic planStrategic plan
Strategic plan
 
How to find investigators for clinical trials
How to find investigators for clinical trialsHow to find investigators for clinical trials
How to find investigators for clinical trials
 
Michael vassar interview
Michael vassar interviewMichael vassar interview
Michael vassar interview
 
7 Essential for Doctors intersted in a Career in Health tech
7 Essential for Doctors intersted in a Career in Health tech7 Essential for Doctors intersted in a Career in Health tech
7 Essential for Doctors intersted in a Career in Health tech
 

More from TrialJoin

What to Do When There Are Adverse Events and Serious Adverse Events
What to Do When There Are Adverse Events and Serious Adverse EventsWhat to Do When There Are Adverse Events and Serious Adverse Events
What to Do When There Are Adverse Events and Serious Adverse EventsTrialJoin
 
New Drug Application - How to Speed Up FDA Approval
New Drug Application - How to Speed Up FDA ApprovalNew Drug Application - How to Speed Up FDA Approval
New Drug Application - How to Speed Up FDA ApprovalTrialJoin
 
Negotiating Clinical Research Budgets: Most Commonly Neglected Items
Negotiating Clinical Research Budgets: Most Commonly Neglected ItemsNegotiating Clinical Research Budgets: Most Commonly Neglected Items
Negotiating Clinical Research Budgets: Most Commonly Neglected ItemsTrialJoin
 
Explaining the Different Types of Routine Monitoring Visits
Explaining the Different Types of Routine Monitoring VisitsExplaining the Different Types of Routine Monitoring Visits
Explaining the Different Types of Routine Monitoring VisitsTrialJoin
 
Essential Regulatory Documents in Clinical Trials
Essential Regulatory Documents in Clinical TrialsEssential Regulatory Documents in Clinical Trials
Essential Regulatory Documents in Clinical TrialsTrialJoin
 
Clinical Project Manager: Leading Causes of Problem Solving Inefficiencies
Clinical Project Manager: Leading Causes of Problem Solving InefficienciesClinical Project Manager: Leading Causes of Problem Solving Inefficiencies
Clinical Project Manager: Leading Causes of Problem Solving InefficienciesTrialJoin
 
Financing - Investigator Payment Models & Best Budget Practices
Financing - Investigator Payment Models & Best Budget PracticesFinancing - Investigator Payment Models & Best Budget Practices
Financing - Investigator Payment Models & Best Budget PracticesTrialJoin
 
Legal Compensation for Referring Doctors in Clinical Trials
Legal Compensation for Referring Doctors in Clinical TrialsLegal Compensation for Referring Doctors in Clinical Trials
Legal Compensation for Referring Doctors in Clinical TrialsTrialJoin
 
Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...
Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...
Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...TrialJoin
 
Regulating the Workload of Your Clinical Research Coordinator (CRC)
Regulating the Workload of Your Clinical Research Coordinator (CRC)Regulating the Workload of Your Clinical Research Coordinator (CRC)
Regulating the Workload of Your Clinical Research Coordinator (CRC)TrialJoin
 
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to Know
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to KnowMonitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to Know
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to KnowTrialJoin
 
Differences Between Satellite Sites and Multi Site Research Clinics
Differences Between Satellite Sites and Multi Site Research ClinicsDifferences Between Satellite Sites and Multi Site Research Clinics
Differences Between Satellite Sites and Multi Site Research ClinicsTrialJoin
 
Standard of Care Costs vs Study-Related Costs
Standard of Care Costs vs Study-Related CostsStandard of Care Costs vs Study-Related Costs
Standard of Care Costs vs Study-Related CostsTrialJoin
 
Resolving Sponsors’ Objections in Clinical Trials
Resolving Sponsors’ Objections in Clinical TrialsResolving Sponsors’ Objections in Clinical Trials
Resolving Sponsors’ Objections in Clinical TrialsTrialJoin
 
Maintaining high levels of motivation and commitment of your clinical researc...
Maintaining high levels of motivation and commitment of your clinical researc...Maintaining high levels of motivation and commitment of your clinical researc...
Maintaining high levels of motivation and commitment of your clinical researc...TrialJoin
 
Increasing the quality of clinical research: best ways to solve the most comm...
Increasing the quality of clinical research: best ways to solve the most comm...Increasing the quality of clinical research: best ways to solve the most comm...
Increasing the quality of clinical research: best ways to solve the most comm...TrialJoin
 
Helpful information for sponsors: How to best spend your resources and avoid ...
Helpful information for sponsors: How to best spend your resources and avoid ...Helpful information for sponsors: How to best spend your resources and avoid ...
Helpful information for sponsors: How to best spend your resources and avoid ...TrialJoin
 
Finding study leads, sharing them among sites and avoiding the enrollment of ...
Finding study leads, sharing them among sites and avoiding the enrollment of ...Finding study leads, sharing them among sites and avoiding the enrollment of ...
Finding study leads, sharing them among sites and avoiding the enrollment of ...TrialJoin
 
Explaining the importance of a database lock in clinical research
Explaining the importance of a database lock in clinical researchExplaining the importance of a database lock in clinical research
Explaining the importance of a database lock in clinical researchTrialJoin
 
Compensation for your PI explained in depth
Compensation for your PI explained in depthCompensation for your PI explained in depth
Compensation for your PI explained in depthTrialJoin
 

More from TrialJoin (20)

What to Do When There Are Adverse Events and Serious Adverse Events
What to Do When There Are Adverse Events and Serious Adverse EventsWhat to Do When There Are Adverse Events and Serious Adverse Events
What to Do When There Are Adverse Events and Serious Adverse Events
 
New Drug Application - How to Speed Up FDA Approval
New Drug Application - How to Speed Up FDA ApprovalNew Drug Application - How to Speed Up FDA Approval
New Drug Application - How to Speed Up FDA Approval
 
Negotiating Clinical Research Budgets: Most Commonly Neglected Items
Negotiating Clinical Research Budgets: Most Commonly Neglected ItemsNegotiating Clinical Research Budgets: Most Commonly Neglected Items
Negotiating Clinical Research Budgets: Most Commonly Neglected Items
 
Explaining the Different Types of Routine Monitoring Visits
Explaining the Different Types of Routine Monitoring VisitsExplaining the Different Types of Routine Monitoring Visits
Explaining the Different Types of Routine Monitoring Visits
 
Essential Regulatory Documents in Clinical Trials
Essential Regulatory Documents in Clinical TrialsEssential Regulatory Documents in Clinical Trials
Essential Regulatory Documents in Clinical Trials
 
Clinical Project Manager: Leading Causes of Problem Solving Inefficiencies
Clinical Project Manager: Leading Causes of Problem Solving InefficienciesClinical Project Manager: Leading Causes of Problem Solving Inefficiencies
Clinical Project Manager: Leading Causes of Problem Solving Inefficiencies
 
Financing - Investigator Payment Models & Best Budget Practices
Financing - Investigator Payment Models & Best Budget PracticesFinancing - Investigator Payment Models & Best Budget Practices
Financing - Investigator Payment Models & Best Budget Practices
 
Legal Compensation for Referring Doctors in Clinical Trials
Legal Compensation for Referring Doctors in Clinical TrialsLegal Compensation for Referring Doctors in Clinical Trials
Legal Compensation for Referring Doctors in Clinical Trials
 
Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...
Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...
Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...
 
Regulating the Workload of Your Clinical Research Coordinator (CRC)
Regulating the Workload of Your Clinical Research Coordinator (CRC)Regulating the Workload of Your Clinical Research Coordinator (CRC)
Regulating the Workload of Your Clinical Research Coordinator (CRC)
 
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to Know
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to KnowMonitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to Know
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to Know
 
Differences Between Satellite Sites and Multi Site Research Clinics
Differences Between Satellite Sites and Multi Site Research ClinicsDifferences Between Satellite Sites and Multi Site Research Clinics
Differences Between Satellite Sites and Multi Site Research Clinics
 
Standard of Care Costs vs Study-Related Costs
Standard of Care Costs vs Study-Related CostsStandard of Care Costs vs Study-Related Costs
Standard of Care Costs vs Study-Related Costs
 
Resolving Sponsors’ Objections in Clinical Trials
Resolving Sponsors’ Objections in Clinical TrialsResolving Sponsors’ Objections in Clinical Trials
Resolving Sponsors’ Objections in Clinical Trials
 
Maintaining high levels of motivation and commitment of your clinical researc...
Maintaining high levels of motivation and commitment of your clinical researc...Maintaining high levels of motivation and commitment of your clinical researc...
Maintaining high levels of motivation and commitment of your clinical researc...
 
Increasing the quality of clinical research: best ways to solve the most comm...
Increasing the quality of clinical research: best ways to solve the most comm...Increasing the quality of clinical research: best ways to solve the most comm...
Increasing the quality of clinical research: best ways to solve the most comm...
 
Helpful information for sponsors: How to best spend your resources and avoid ...
Helpful information for sponsors: How to best spend your resources and avoid ...Helpful information for sponsors: How to best spend your resources and avoid ...
Helpful information for sponsors: How to best spend your resources and avoid ...
 
Finding study leads, sharing them among sites and avoiding the enrollment of ...
Finding study leads, sharing them among sites and avoiding the enrollment of ...Finding study leads, sharing them among sites and avoiding the enrollment of ...
Finding study leads, sharing them among sites and avoiding the enrollment of ...
 
Explaining the importance of a database lock in clinical research
Explaining the importance of a database lock in clinical researchExplaining the importance of a database lock in clinical research
Explaining the importance of a database lock in clinical research
 
Compensation for your PI explained in depth
Compensation for your PI explained in depthCompensation for your PI explained in depth
Compensation for your PI explained in depth
 

Recently uploaded

Cervical screening – taking care of your health flipchart (Vietnamese)
Cervical screening – taking care of your health flipchart (Vietnamese)Cervical screening – taking care of your health flipchart (Vietnamese)
Cervical screening – taking care of your health flipchart (Vietnamese)Cancer Institute NSW
 
Denture base resins materials and its mechanism of action
Denture base resins materials and its mechanism of actionDenture base resins materials and its mechanism of action
Denture base resins materials and its mechanism of actionDr.shiva sai vemula
 
Dermatome and myotome test & pathology.pdf
Dermatome and myotome test & pathology.pdfDermatome and myotome test & pathology.pdf
Dermatome and myotome test & pathology.pdfniloofarbarzegari76
 
Integrated Neuromuscular Inhibition Technique (INIT)
Integrated Neuromuscular Inhibition Technique (INIT)Integrated Neuromuscular Inhibition Technique (INIT)
Integrated Neuromuscular Inhibition Technique (INIT)Anjali Parmar
 
Hemodialysis: Chapter 1, Physiological Principles of Hemodialysis - Dr.Gawad
Hemodialysis: Chapter 1, Physiological Principles of Hemodialysis - Dr.GawadHemodialysis: Chapter 1, Physiological Principles of Hemodialysis - Dr.Gawad
Hemodialysis: Chapter 1, Physiological Principles of Hemodialysis - Dr.GawadNephroTube - Dr.Gawad
 
Evidence-based practiceEBP) in physiotherapy
Evidence-based practiceEBP) in physiotherapyEvidence-based practiceEBP) in physiotherapy
Evidence-based practiceEBP) in physiotherapyNehaa Dubey
 
DR. Neha Mehta Best Psychologist.in India
DR. Neha Mehta Best Psychologist.in IndiaDR. Neha Mehta Best Psychologist.in India
DR. Neha Mehta Best Psychologist.in IndiaNehamehta128467
 
PREPARATION FOR EXAMINATION FON II .pptx
PREPARATION FOR EXAMINATION FON II .pptxPREPARATION FOR EXAMINATION FON II .pptx
PREPARATION FOR EXAMINATION FON II .pptxPupayumnam1
 
Is Rheumatoid Arthritis a Metabolic Disorder.pptx
Is Rheumatoid Arthritis a Metabolic Disorder.pptxIs Rheumatoid Arthritis a Metabolic Disorder.pptx
Is Rheumatoid Arthritis a Metabolic Disorder.pptxSamar Tharwat
 
CAS 110-63-4 BDO Liquid 1,4-Butanediol 1 4 BDO Warehouse Supply For Excellent...
CAS 110-63-4 BDO Liquid 1,4-Butanediol 1 4 BDO Warehouse Supply For Excellent...CAS 110-63-4 BDO Liquid 1,4-Butanediol 1 4 BDO Warehouse Supply For Excellent...
CAS 110-63-4 BDO Liquid 1,4-Butanediol 1 4 BDO Warehouse Supply For Excellent...ocean4396
 
5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials
5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials
5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materialsSherrylee83
 
Vaccines: A Powerful and Cost-Effective Tool Protecting Americans Against Dis...
Vaccines: A Powerful and Cost-Effective Tool Protecting Americans Against Dis...Vaccines: A Powerful and Cost-Effective Tool Protecting Americans Against Dis...
Vaccines: A Powerful and Cost-Effective Tool Protecting Americans Against Dis...PhRMA
 
Video capsule endoscopy (VCE ) in children
Video capsule endoscopy (VCE ) in childrenVideo capsule endoscopy (VCE ) in children
Video capsule endoscopy (VCE ) in childrenRaju678948
 
Factors Affecting child behavior in Pediatric Dentistry
Factors Affecting child behavior in Pediatric DentistryFactors Affecting child behavior in Pediatric Dentistry
Factors Affecting child behavior in Pediatric DentistryDr Simran Deepak Vangani
 
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1DR SETH JOTHAM
 
Introducing VarSeq Dx as a Medical Device in the European Union
Introducing VarSeq Dx as a Medical Device in the European UnionIntroducing VarSeq Dx as a Medical Device in the European Union
Introducing VarSeq Dx as a Medical Device in the European UnionGolden Helix
 
Muscle Energy Technique (MET) with variant and techniques.
Muscle Energy Technique (MET) with variant and techniques.Muscle Energy Technique (MET) with variant and techniques.
Muscle Energy Technique (MET) with variant and techniques.Anjali Parmar
 
The Orbit & its contents by Dr. Rabia I. Gandapore.pptx
The Orbit & its contents by Dr. Rabia I. Gandapore.pptxThe Orbit & its contents by Dr. Rabia I. Gandapore.pptx
The Orbit & its contents by Dr. Rabia I. Gandapore.pptxDr. Rabia Inam Gandapore
 
DIGITAL RADIOGRAPHY-SABBU KHATOON .pptx
DIGITAL RADIOGRAPHY-SABBU KHATOON  .pptxDIGITAL RADIOGRAPHY-SABBU KHATOON  .pptx
DIGITAL RADIOGRAPHY-SABBU KHATOON .pptxSabbu Khatoon
 
CONGENITAL HYPERTROPHIC PYLORIC STENOSIS by Dr M.KARTHIK EMMANUEL
CONGENITAL HYPERTROPHIC PYLORIC STENOSIS  by Dr M.KARTHIK EMMANUELCONGENITAL HYPERTROPHIC PYLORIC STENOSIS  by Dr M.KARTHIK EMMANUEL
CONGENITAL HYPERTROPHIC PYLORIC STENOSIS by Dr M.KARTHIK EMMANUELMKARTHIKEMMANUEL
 

Recently uploaded (20)

Cervical screening – taking care of your health flipchart (Vietnamese)
Cervical screening – taking care of your health flipchart (Vietnamese)Cervical screening – taking care of your health flipchart (Vietnamese)
Cervical screening – taking care of your health flipchart (Vietnamese)
 
Denture base resins materials and its mechanism of action
Denture base resins materials and its mechanism of actionDenture base resins materials and its mechanism of action
Denture base resins materials and its mechanism of action
 
Dermatome and myotome test & pathology.pdf
Dermatome and myotome test & pathology.pdfDermatome and myotome test & pathology.pdf
Dermatome and myotome test & pathology.pdf
 
Integrated Neuromuscular Inhibition Technique (INIT)
Integrated Neuromuscular Inhibition Technique (INIT)Integrated Neuromuscular Inhibition Technique (INIT)
Integrated Neuromuscular Inhibition Technique (INIT)
 
Hemodialysis: Chapter 1, Physiological Principles of Hemodialysis - Dr.Gawad
Hemodialysis: Chapter 1, Physiological Principles of Hemodialysis - Dr.GawadHemodialysis: Chapter 1, Physiological Principles of Hemodialysis - Dr.Gawad
Hemodialysis: Chapter 1, Physiological Principles of Hemodialysis - Dr.Gawad
 
Evidence-based practiceEBP) in physiotherapy
Evidence-based practiceEBP) in physiotherapyEvidence-based practiceEBP) in physiotherapy
Evidence-based practiceEBP) in physiotherapy
 
DR. Neha Mehta Best Psychologist.in India
DR. Neha Mehta Best Psychologist.in IndiaDR. Neha Mehta Best Psychologist.in India
DR. Neha Mehta Best Psychologist.in India
 
PREPARATION FOR EXAMINATION FON II .pptx
PREPARATION FOR EXAMINATION FON II .pptxPREPARATION FOR EXAMINATION FON II .pptx
PREPARATION FOR EXAMINATION FON II .pptx
 
Is Rheumatoid Arthritis a Metabolic Disorder.pptx
Is Rheumatoid Arthritis a Metabolic Disorder.pptxIs Rheumatoid Arthritis a Metabolic Disorder.pptx
Is Rheumatoid Arthritis a Metabolic Disorder.pptx
 
CAS 110-63-4 BDO Liquid 1,4-Butanediol 1 4 BDO Warehouse Supply For Excellent...
CAS 110-63-4 BDO Liquid 1,4-Butanediol 1 4 BDO Warehouse Supply For Excellent...CAS 110-63-4 BDO Liquid 1,4-Butanediol 1 4 BDO Warehouse Supply For Excellent...
CAS 110-63-4 BDO Liquid 1,4-Butanediol 1 4 BDO Warehouse Supply For Excellent...
 
5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials
5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials
5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials
 
Vaccines: A Powerful and Cost-Effective Tool Protecting Americans Against Dis...
Vaccines: A Powerful and Cost-Effective Tool Protecting Americans Against Dis...Vaccines: A Powerful and Cost-Effective Tool Protecting Americans Against Dis...
Vaccines: A Powerful and Cost-Effective Tool Protecting Americans Against Dis...
 
Video capsule endoscopy (VCE ) in children
Video capsule endoscopy (VCE ) in childrenVideo capsule endoscopy (VCE ) in children
Video capsule endoscopy (VCE ) in children
 
Factors Affecting child behavior in Pediatric Dentistry
Factors Affecting child behavior in Pediatric DentistryFactors Affecting child behavior in Pediatric Dentistry
Factors Affecting child behavior in Pediatric Dentistry
 
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
 
Introducing VarSeq Dx as a Medical Device in the European Union
Introducing VarSeq Dx as a Medical Device in the European UnionIntroducing VarSeq Dx as a Medical Device in the European Union
Introducing VarSeq Dx as a Medical Device in the European Union
 
Muscle Energy Technique (MET) with variant and techniques.
Muscle Energy Technique (MET) with variant and techniques.Muscle Energy Technique (MET) with variant and techniques.
Muscle Energy Technique (MET) with variant and techniques.
 
The Orbit & its contents by Dr. Rabia I. Gandapore.pptx
The Orbit & its contents by Dr. Rabia I. Gandapore.pptxThe Orbit & its contents by Dr. Rabia I. Gandapore.pptx
The Orbit & its contents by Dr. Rabia I. Gandapore.pptx
 
DIGITAL RADIOGRAPHY-SABBU KHATOON .pptx
DIGITAL RADIOGRAPHY-SABBU KHATOON  .pptxDIGITAL RADIOGRAPHY-SABBU KHATOON  .pptx
DIGITAL RADIOGRAPHY-SABBU KHATOON .pptx
 
CONGENITAL HYPERTROPHIC PYLORIC STENOSIS by Dr M.KARTHIK EMMANUEL
CONGENITAL HYPERTROPHIC PYLORIC STENOSIS  by Dr M.KARTHIK EMMANUELCONGENITAL HYPERTROPHIC PYLORIC STENOSIS  by Dr M.KARTHIK EMMANUEL
CONGENITAL HYPERTROPHIC PYLORIC STENOSIS by Dr M.KARTHIK EMMANUEL
 

Essentials for Setting up a New Clinical Research Center

  • 1. Essentials for Setting up a New Clinical Research Center
  • 2. Introduction This one is for all the doctors and medical specialists who are interested in opening up their own research clinic. As a doctor who’s interested in this option, we imagine that you’ve already seen a clinical research environment either by participating as a sub-investigator or a PI (principal investigator). If this is the case and you’re already familiar with everything that clinical research entails, then you’re in a good position to start your own clinical research center or research clinic. 2
  • 3. First of all, just like any other business, in clinical research you should also start small and grow step by step. This means that you can start clinical research in your own private practice. After a while, if you see that you’re successful and everything is going well, you can choose if you want to enlarge your clinic or open up a new one. How to Start?
  • 4. 4 Essentials for Setting Up a Research Clinic If you own a private practice with a lot of patients in your database, then opening your own research clinic is an excellent idea. The essentials for opening a research clinic can differ based on your budget, so here we’ll only give you the minimum requirements necessary for the beginning. All of these requirements are based on conducting 5 to 10 studies a year in your clinic.
  • 5. Your Hospital 5 Essentials for Setting Up a Research Clinic The first and most necessary thing you’ll need is an exam room for the patients who enroll in the trials. We are putting this as a separate point because usually, your regular exam room for all your other patients isn’t a good fit for the study subjects, especially if you have a busy clinic. So, having an extra exam room is a must in this case! EXAM ROOM You are probably already sitting in this room! Since you are going to be the owner of this research clinic, we suppose that you will be the PI or the Principal Investigator. If so, then you’ll need an office for yourself, and this can be the office that you already use for your private practice. PI ROOM
  • 6. Your Hospital 6 Essentials for Setting Up a Research Clinic Since most of the tasks in a trial are delegated to coordinators, you will need to provide them with a coordinators’ office where they can work. Coordinators are some of the most overworked people during a trial, so it’s impossible for them to work without an office. Make sure that the office you prepare for coordinators is only for them, and not a common office with monitors coming in for visits. COORDINATORS ROOM Another important office space that you’ll need is the room for monitors. Always try to make a separate room only for when monitors come in, so that you avoid situations when the monitors find documents or papers they aren’t supposed to. For example, if a monitor comes for a visit in the middle of a busy day, the coordinators’ office will usually be a mess, so if you settle the monitors in the same office, they can find many more things to complain about. This is why having a clean monitor-only room is important for every research clinic or clinical research center. MONITORS ROOM Different rooms for CRCs and CRAs!!!
  • 7. Your Hospital 7 Essentials for Setting Up a Research Clinic If you have the budget for it, try to have a separate IP room that will be locked, with limited access, no traffic, and with controlled temperature. In reality, the minimum requirement is an IP cabinet. However, placing this cabinet in a room where unauthorized staff and patients walk through is risky and can cause you many problems with the FDA, the sponsor, and the monitors. If you aren’t able to afford to have a separate IP room, then make sure to place the IP cabinet somewhere where patients won’t have access to it. And remember, the IP cabinet also has to be double locked and with controlled temperature. IP ROOM / IP CABINET Yet another thing you’ll need in your clinic is a centrifuge and a fridge. These are needed both for the investigational drug (IP) as well as for blood and other specimens that will have to be kept and processed throughout the trial. CENTRIFUGE AND FRIDGE
  • 8. Your Hospital 8 Essentials for Setting Up a Research Clinic A common mistake that many clinics make is underestimating how much space source and regulatory documents can take. There are thousands of documents involved in a single protocol, so make sure that your research center has enough room to store all these important documents. PHYSICAL SPACE FOR DOCUMENTATION STORAGE Most clinics will usually need to have a lab where they can draw blood, process it (once you have a waiver as a permission), and ship the results. In the past, ECG machines were usually provided by the sponsor, but nowadays, it’s expected that sites have their own ECG machines available for study participants. LABORATORY AND ECG
  • 9. Your Hospital 9 Essentials for Setting Up a Research Clinic As we’ve mentioned many times before, clinical trials are complex and they require a lot of correspondence with vendors, patients, staff, sponsor, etc. For this reason, it’s practically impossible to work without a fax machine and internet connection. On top of that, most sites are slowly transferring completely online these days, in clouds and virtual workspaces, and they start using EDC systems, CTMS, etc. All of these things are extremely important, so having a good connection is a must! FAX AND INTERNET Last but not least, you’ll need time! Even though as a PI you’ll be able to delegate most of your tasks to other site staff such as coordinators, you’ll still need to realize that clinical research does require time. At the beginning, until you get used to everything and learn things, you can try giving half of your time to clinical research and the other half to your private practice. Later on, when things are running smoothly with the trial, you can probably delegate more of your responsibilities. Like this, you’ll have more time to dedicate to your private practice while still enjoying the benefits of doing research TIME
  • 10. www.trialjoin.com CONCLUSION Above, we’ve given you 10 things that can serve you as a checklist of the minimum requirements essential for setting up a new clinical research center. Even though it might seem complicated at the beginning, if you have a busy private practice and a large patient pool then this is probably the perfect thing for you to do. Aside from the medical advancements that you’ll be a part of, clinical trials are also lucrative, so the benefits of opening a research clinic are definitely worth the risks. 10