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Downloadable Templates and Tools for Clinical Research

Welcome to global health trials' tools and templates library. please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. please click on the orange text to download each template., the templates below have been shared by other groups, and are free to use and adapt for your researchstudies. please ensure that you read and adapt them carefully for your own setting, and that you reference global health trials and the global health network when you use them. to share your own templates and sops, or comment on these, please email [email protected]. we look forward to hearing from you.

These templates and tools are ordered by category, so please scroll down to find what you need.

To share your own templates and SOPs, or comment on these, please email [email protected]. We look forward to hearing from you!

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This is Degena Bahrey Tadesse from Tigray, Ethiopia. I am new for this web I am assistant professor in Adult Health Nursing Could you share me the sample/templet research proposal for Global Research Nurses Pump-priming Grants 2023: Research Project Award

I have learned lot..Thanks..

i was wondering why there is no SOP on laboratory procedures ?

Hi, Can you provide me the SOP for electronic signatures in Clinical trial

Do you have an "SOP for Telephonic site selection visit". Kindly Share on my registered mail ID

Thank you for sharing the resources. It is very kind of you.

Hi These tolls are very useful! Thank you

Do you have a task and responsability matrix template for clinical trial managment ? Best

I am very much happy to find myself here as a clinician

Dear Getrude

We have a free 14-module course on research ethics on our training centre; you'll receive a certificate if you complete all the modules and quizzes. You can take it in your own time. Just visit 'Training centre' in the tabs above, then 'short courses'.

Kind regards The Editorial Team

need modules on free online gcp course on research ethics

Estimados: me parece excelente el aporte que han hecho dado que aporta. por un lado a mejorar la transparencia del trabajo como a facilitar el seguimiento y supervisión de los mismos. Muchas gracias por ello

We also have an up to date list of global health events available here: https://globalhealthtrials.tghn.org/community/training-events/

Dear Nazish

Thank you, I am glad you found the seminars and the training courses useful. We list many training events (all relevant to Global Health, and as many of them as possible are either free or subsidised) on the 'community' web pages above. Keep an eye on those for events and activities which you can get involved with. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events.

Thanks so much. These are very helpful seminars. Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Appreciate your help.

Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! You can find free seminars with sound and slides here: https://globalhealthtrainingcentre.tghn.org/webinars/ , and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning . Certificates are awarded for the eLearning courses for those scoring over 80% in the quiz at the end of each course. If you need anything else, do ask! Kind regards The Editorial Team

Hi, I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

This site is impeccable and very useful for my job!!!!

Thank you for your kind comments.

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A Checklist for Optimizing Clinical Trial Study Startup Activities

• Frank Conte Vice President, Strategic Partnerships;

Study startup is a complicated, multi-faceted, and time-consuming component of the clinical research lifecycle, one notoriously prone to delays. The key challenge of successful, timely study startup requires careful coordination across multiple constituencies within and external to a research organization. As a result, it is easy to lose track of all the various steps necessary to activate a study efficiently and compliantly.   

With this in mind, we have outlined a checklist for researchers who are looking for guidance on study startup activities. We’ve included suggestions for optimizing each step to minimize delays and set your study on a clear path for success.    

About This List  

Careful planning from day one is essential for study success. The primary goal is to reduce the amount of time and resources required to activate a study.   Lists of various study startup activities vary widely depending on the level of detail provided. These elements are most critical and demand the most attention from sponsors, contract research organizations (CROs), monitors, and sites.  

Key Stakeholders  

Sponsors: The trial sponsor is primarily responsible for many study startup activities including but not limited to :   

• Writing the protocol  
• Funding and managing the budget for the study  
• Engaging a CRO to assist in the execution of the trial  
• Overseeing startup activities  
• Collecting, storing, and submitting the data and documents associated with the trial  

CROs: Some sponsors may involve a CRO to manage components of the study. Typically, CROs are respons ible for :   

• Budget negotiation  
• Engaging and selecting sites  
• Identifying patient populations and supporting recruitment  
• Overseeing training, conduct, and other processes across the study  

Monitors: Typically affiliated with the sponsor, monitors ensure appropriate and safe study conduct, as well as overseeing the progress of activating a study. Whether they monitor remotely or in person, they require detailed access to key study documents, standard operating procedures (SOPs), and more at each research site involved in the study.   

Research sites: S taff and investigators at the research site play a critical role in planning and conducting a clinical trial. They are responsible for but not limited to:   

• Conducting clinical trial visits and procedures  
• Collecting data during the visit  
• Connecting with patients to recruit and retain participa nts  
• Securing oversight committee approvals (IRB, IBC, SRC, RSC, COI, feasibility)  
• Executing billing and financial workflows to maintain operations and compliance  
• Communicating information to study stakeholders include status updates, essential protocol documents, and more  

1. Sponsors: Design and Optimize Your Protocol  

The clinical trial protocol organizes and dictates every component of study conduct. While each detail of the protocol is essential to study success, it also must holistically and realistically support study outcome goals. While many believe study startup is entirely reactive to the protocol, optimizing the protocol before it is ever in motion can greatly impact trial success. This may include reevaluating inclusion and exclusion criteria, enrollment goals, complicated or costly procedures, or other components.  

Early conversations with sites and patient groups will help ensure the visits and procedures are reasonable and achievable as study theory moves to the real-life setting.  

2. Sponsors : Build Your Budget  

Regardless of the type of study you are planning, building the budget is step one. You must get a handle on all the costs for activities happening throughout the life of the trial. Now is the time to thoroughly consider all the potential tasks and associated fees required. Consider the following:  

• Do you need help writing the protocol?   
• Do you need a data monitoring committee?   
• Do you need endpoint adjudication?   
• Do you need assistance or consulting help on any other matter?   
• Do you need specific technology to collect or exchange data across stakeholders?   

All of these, and many others, will impact your study’s budget and should be accounted for at the outset.  

Let data inform your budget building process. Explore our resource: Study Activation Survey Results: Budget Negotiation  

3. Sponsors and Sites : Submit Materials to Your IRB for Approval  

Partnering with an experienced IRB increases opportunities to streamline the activation process. As you’re beginning your partnership with your IRB, setting clear expectations for each organization is beneficial during study startup and will also help maintain the relationship for future studies.  

Setting up a study kickoff call can ensure any key milestones or special requirements are understood. Scheduling this conversation upfront with an IRB will save both the sponsor and IRB time during review time.  

Need additional guidance on review requirements?   

• Local Versus Central IRBs: What’s the Difference?  
• What Level of Review Does Your Study Need?  
• Does This Study Require IBC Review?  
• The Value of Early Engagement with Your IRB

4. Sponsors and CROs : Identify the Right Sites for Your Study  

To streamline startup activities, it is important to identify the most efficient and appropriate sites to conduct your study while your team might have a great relationship with a physician at a particular institution, it does not mean they have the appropriate patient population to achieve enrollment goals for the trial, or their institution has the resources to efficiently launch and run a study.   

Unfortunately, finding sites is a perennial problem—mostly because it is difficult to identify and connect with sites with the appropriate patient population for a study. Or once found, the sites are shown to lack sufficient staffing or resources to take on additional trials.   

More than a list of sites, Advarra’s SiteIQ solution provides detailed site performance metrics synthesized from actual completed studies, providing performance metrics and insights.  

5. Sponsors, CROs, and Sites : Conduct Feasibility Evaluation  

Protocol feasibility is the process of reviewing clinical trial logistics to determine if the site’s available resources are sufficient for trial conduct.

Site selection is informed early and most significantly by the feasibility questionnaire, a survey sent to all prospective sites. But if those questionnaires are deployed blindly to sites before diligent site planning occurs, it can result in responses failing to tell sponsors enough about the site’s feasibility for that specific protocol. 

A feasibility evaluation should include:  

• Financial viability  
• Available resources  
• Past performance and ability to accrue  
• Alignment with the study timeline  
• Current staffing and turnover  
• Competing trials and populations  

Sites are also responsible for completing and returning site feasibility questionnaires to inform selection and identify opportunities to take part in new studies. However, many questionnaires are redundant, or may not accurately capture a site’s ability to successfully conduct a study.   

6. Sponsors and Monitors : Conduct Pre-study Site Visits/Screening Visits  

Pre-study visits are the final and most crucial step in selecting appropriate sites. These visits are especially vital in cases where the research team has had no prior experience with the site.  

7. Sponsors and Sites : Initiate and Negotiate the Clinical Trial Agreement (CTA)  

The CTA is a legally binding agreement executed between sponsors and sites; one meant to protect both parties’ rights and interests. It covers delegation of responsibilities, obligations, allocation of risk, and financial commitments. Expect negotiations around this critical document and allocate time for them.  

8. Sponsors and Sites : Collect and Exchange Regulatory Documents and Critical Submissions  

Collecting and exchanging what are sometimes called the “essential” documents of the study startup process, is another place where teams will typically encounter issues slowing their progress, especially as these documents are numerous and complex. They fall into three general categories:   

• Federal/National Regulatory (i.e. FDA-USA, BfArM-Germany)  
• Institutional review board (IRB)/ethics committee (EC) submissions  
• SOP requirements  

Optimizing this process centers on removing redundancies and centralizing communication and exchange. For sponsors, leverage a centralized location – like in Advarra’s Longboat Platform – to distribute, monitor, and retrieve documents across your sites globally. Centralization also minimizes requests for redundant information, or for documents you’ve already received like CV’s, training certificates, and more.   

For sites, it is important to leverage site-centric technology connected with the sponsor to ensure you’re receiving essential study communications like protocol amendments or updated informed consent forms (ICFs) . By bringing your own technology to this critical step in study startup, you can maximize internal workflows when deploying documents to internal teams like quickly routing for investigator signatures and sign off, as well as returning documents quickly back to the sponsor

Learn more about how Advarra is streamlining document exchange across sites, CROs, and sponsors.  

9. Sponsors and Sites : Deploy and Complete Training  

Before a study begins enrollment, all relevant site staff must receive training and completely understand their roles. Any misunderstanding—or a lack of understanding—among site staff is a main contributor to delaying study startup progress or increasing timelines due to protocol deviations. Make sure your clinical team members thoroughly understand all the procedures, clinical and administrative, required of them by providing engaging and efficient training for each study.   

 Explore more resources on training best practices.  

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Dive Deeper into Study Startup Optimization  

Amid a million reasons for delays, there are always opportunities to improve and optimize study startup. In our white paper, ‘Expedite Study Startup: Four Strategies to Optimize Site Activation’ we will outline how organizations can expedite study startup through streamlining site selection, training, ethics review, and site initiation.  

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Site Activation: The Key to More Efficient Clinical Trials

A new study of hundreds of thousands of clinical trial records reveals that the overall length of a trial is directly related to how long it takes to activate the study sites - and that most companies are wasting precious weeks and even months in activation. Here's how to improve your performance.

Nothing in any other industry quite compares to the pharmaceutical industry’s clinical development process.In 2007, $28 billion dollars were spent on drug development. Nowadays a single clinical trial can be capital intensive (up to $500 million), with massive geographic coverage (as many as 53 countries), long duration (five years or longer), and enroll a large number of patients (20,000- to 50,000-patient trials are no longer rare).

A median Phase III clinical trial involves about 800 patients, 50 investigator sites, and two years (700 days) from First Subject First Visit (FSFV) to Last Subject Last Visit (LSLV). Add in the costs of per-patient medical procedures, drug supplies, laboratory work, and sponsor’s personnel, and a median-sized clinical trial can cost upwards of $25 million, about $36,000 every single day.

Clearly clinical trials are extremely important to the pharmaceutical industry both as the source for clinical data and as an enormous cost center. And the patient enrollment phase of a trial is the most variable part of the process-that is, the spot where we could most reasonably expect to drive down costs. But we still lack a fundamental understanding of patient enrollment as a business process. While many companies are attempting to manage trials better, it is not surprising to see that their approaches, even those of established industry experts, lack in structure and objectivity and occasionally make things worse-for example, by making false assumptions about who has final responsibility for recruiting patients.

Because drug development operations are unusually complex, they cannot easily be handled by applying general operations management principles. There is still a need, however, to introduce quantitative methods to better describe and improve clinical trial execution. Luckily, the industry is becoming increasingly transparent, so that more and more operational data are available for analysis. I have spent the past few years building a database tracking the performance of clinical research sites (collecting 20,000 to 50,000+ site performance data every week). These data point to some strikingly clear directions for improving clinical trial operations.

Site Activation Is the Driver Patient enrollment, at its simplest, consists of three steps:

• Site selection
• Site activation
• Patient recruitment

Site selection is the process of identifying a sufficient number of and good-quality investigators to conduct the trial. This is one of the greatest challenges in clinical trial execution. You need to find someone with considerable medical skills, commitment to research, good facilities, willingness to fill in endless forms, and last but not least, access to patients who fit the patient selection standard and will agree to enroll.

It takes several steps to bring a site to the point where it is ready to recruit patients. This process is called site activation , and it consists of a variety of tasks including:

• Negotiate a financial contract
• Gain approval from Institutional Review Board (IRB) or, in Europe, Ethics Board (EB)
• Provide clinical supplies
• Obtain other documents from site (CV, financial disclosure, etc)

Though the two activities are entirely different in content, patient recruitment generally occurs simultaneously with site activation. This is partly because clinical trial teams are often not sure they have an adequate number of sites until they come very close to their enrollment target. As a result, they tend to keep activating sites until enrollment is almost complete. Inevitably, recruiting at some sites is shut down within a matter of days, creating ill will and frustration.

By analyzing the data, we can come to several conclusions: Site activation is the driver in patient enrollment Many in the industry believe that patient enrollment is the responsibility of the investigator sites, and sponsors play only a supporting role in the process. This is only part of the truth.

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Best Practices for Clinical Site Selection

Practical and Protocol Considerations

Recruitment and retention strategies, regulatory considerations, references:.

Clinical trials are expensive and labor-intensive. Failures within the clinical trial process result in a huge loss of valuable resources and time. [ 1 ] These challenges can stall a clinical trial and delay life-saving medical therapies and devices from entering the healthcare marketplace. Statistics indicate that an overwhelming 80% of clinical studies are not able to meet their enrollment timelines and objectives because of recruitment difficulties. [ 1 , 6 ]

By implementing a series of best practices for clinical site selection, study sponsors can mitigate potential problems. This is accomplished by carefully navigating several key factors involving population profiles, safety, recruitment strategies, funding [ 5 ], and regulatory controls. [ 1 ] Notably, industry experts cite a strong correlation between meeting recruitment goals and clinical site selection. [ 6 ]

Globally, more than 80% of trials fail to enroll on time resulting in an extension of study and or addition of new study sites. [ 13 ]

Subsequently, principal investigators and sponsors place heavy emphasis on identifying site locations with ample resources, such as staff expertise and access to the target subject population. [ 1 , 2 , 3 ] Principal investigators work to optimize clinical trial volunteer engagement and improve protocol adherence, thereby ensuring a successful trial experience for study subjects. Successful clinical sites benefit from past experiences, as survey-based studies indicate that repeated use of clinical sites is common. [ 3 , 6 ] This is especially true if the clinical trial site can demonstrate a  track record of meeting enrollment targets and successfully completing studies. [ 2 , 3 ]

Implementing Best Practices in Clinical Site Selection

Research sites are ramping up their efforts to combat the many challenges associated with site selection by using prior knowledge, proven practices, and enhanced technology. Taking strategic steps to determine early site feasibility [ 8 ] is recommended and should include the following:

• Is the study site situated in an accessible location for study participants?
• Can study visits be decentralized and brought closer to participants?
• Are there measures in place to lower premature dropout rates due to distance?
• What strategies are in place to identify patient eligibility?
• Is there a correlation between the subject population and the disease or condition under study?
• Is the study protocol too complex?
• Is there a clinical site monitoring plan in place?
• Are vulnerable populations involved, such as the elderly, pediatric, or disabled? If so, will they have access to post-trial medical care?
• Are there economic or cultural aspects related to the potential clinical trial site that may deter eligible subjects from participating?
• Are fair selection practices being upheld?
• How are inclusion principles and disparity concerns being addressed?
• What are the enrollment objectives and allotted timeline?
• What is the maximum time allotted for study completion?
• Are there any competing or similar studies being conducted either at the same site or at another location?
• What historical takeaways from previously used clinical sites/teams need to be considered?
• Are there avenues for partnering with medical or social community members to help with recruitment efforts?

What site resources are important in a clinical trial site?

Sponsors must assess potential clinical trial sites for suitable facilities and resources. This is normally accomplished by conducting pre-site visits (PSVs) or site selection visits (SSVs). In preparing for a clinical trial, the details matter, such as maintaining the overall appearance of the potential site to ensure it is professional and welcoming to potential participants. Additionally, an ideal site will have adequate storage space, all needed clinical equipment, privacy options, and an attached or nearby research pharmacy. Flexible site access is also an integral component; participants favor facilities with weekend and late-evening appointments. [ 1 , 3 ]

Can staffing placements make a difference in clinical trial site selection?

Staffing appointments (existing and new) can significantly impact clinical trial site selection. Essential to the process, clinical site staff should be well-versed in Good Clinical Practice guidelines, federal and state regulations, and institutional policies. They should also demonstrate sincerity and compassion with trial participants. Because site coordinators and research nurses are tasked with vital duties such as data collection, they are often in constant contact with participants.

Patients’ perceptions regarding staff availability or interest (as well as having to meet with unfamiliar staff) can greatly impact recruitment and retention. [ 2 ] Patient satisfaction surveys suggest that the interactions between participants and clinical staff members play an influential role in clinical trial recruitment and overall experience . [ 7 ] Establishing patient trust by using consistent methods of communication and follow-thru often results in better participation and adherence.

Is there a risk to using clinical sites with internal site management teams already in place?

Studies concluded that clinical sites with a history of demonstrated site management operations offer the best results in terms of data collection and regulatory compliance. Regulatory duties may be outsourced to companies specializing in clinical site management. Although there is a tremendous benefit to streamlining the clinical process, the challenge of staff inconsistencies and turnover is ever-present. Common pitfalls include high investigator turnover (approximately 40% each year) because of a stressful site environment and burdens related to maintaining regulatory compliance. [10]

Research illustrates how clinical site selection can affect the success of a clinical study or trial. With many overlapping elements, staffing considerations affect multiple areas, including recruitment, retention, regulatory compliance, and overall patient experience. Utilizing best practices alongside a strategic pre-clinical site management plan is key when trying to meet recruitment objectives and study timelines.

As more technological enhancements come into play, we can expect more industry outsourcing to help manage data collection and reporting, in addition to incorporating biometrical data to help improve trial outcomes. While there are many benefits associated with outsourced clinical site management, research sponsors should approach each new potential clinical trial site selection with a fresh lens.

Industry thought leaders emphasize that there is no one-size fits all approach to site selection. By choosing clinical sites carefully and using proven practices, a study sponsor can increase the opportunities for a successful clinical trial.

• Hurtado-Chong, A., A. Joeris, D. Hess, and M. Blauth. 2017. “Improving site selection in clinical studies: a standardized, objective, multistep method and first experience results.” BMJ Open . 12;7(7): e014796. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5734283/ .
• Fogel, D.B. 2018. “Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review.” 2018. Contemp Clin Trials Commun . 11:156-164. doi: 10.1016/j.conctc.2018.08.001.; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/ .
• Dombernowsky, T., M. Haedersdal, U. Lassen, et al . 2019. “Criteria for site selection in industry-sponsored clinical trials: a survey among decision-makers in biopharmaceutical companies and clinical research organizations.” Trials 20 ;708. https://doi.org/10.1186/s13063-019-3790-9
• Feyman Y., F. Provenzano, and F.S. David. 2020. “Disparities in Clinical Trial Access Across US Urban Areas.” JAMA Netw Open . 3(2): e200172. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7049079/ .
• DiMasi, J.A., H.G. Grabowski, and R.W. Hansen. 2015. “The cost of drug development.” N. Engl. J. Med. 372:1972. https://www.nejm.org/doi/10.1056/NEJMc1504317 .
• Bose, S.K., A. Sandhu, and S. Strommenger. 2017. “Clinical trials: A data driven feasibility approach.” Pharmaceutical Outsourcing. Blog. Feb. 1, http://www.pharmoutsourcing.com/Featured-Articles/333830-Clinical-Trials-A-Data-Driven-Feasibility-Approach/ .
• Thoma, A., F. Farrokhyar, L. McKnight, and M. Bhandar. 2010. “How to optimize patient recruitment.” Can. J. Surg. 53:205–210. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2878987/ .
• Rajadhyaksha V. 2010. “Conducting feasibilities in clinical trials: an investment to ensure a good study.” Perspect Clin Res . 1(3):106-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146075/ .
• McMurray, J.J. 2016. “Site Selection and Performance in Clinical Trials.” Circulation: Heart Failure . 9: e003490. https://www.ahajournals.org/doi/full/10.1161/CIRCHEARTFAILURE.116.003490 .
• Getz, K.A., and M.J. Lamberti. 2013. “Global site landscape remains highly fragmented with variable performance.” Tufts Center for the Study of Drug Development Impact Report . 2013; 15 (1-3). March/April.
• Miller J. and J. Millum. 2022. “Ethical considerations in international clinical trial site selection.” Global Health 7: e008012. https://gh.bmj.com/content/bmjgh/7/4/e008012.full.pdf .
• Giutis, K., R.G. Hammermesh, and M. Krasnow. 2021. “Addressing demographic disparities in clinical trials.” Harvard Business Review . https://hbr.org/2021/06/addressing-demographic-disparities-in-clinical-trials .
• Desai M. 2020. “Recruitment and retention of participants in clinical studies: Critical issues and challenges.” Perspect Clin Res . 11(2):51-53. doi: 10.4103/picr.PICR_6_20. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342339 /.

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Site Activation

Activate sites 25%-50% faster.

DrugDev’s site activation technology allows sponsors to activate sites 25-50% faster through a reduction in cycle times, increased transparency, collaborative processes, and more. The technology works by guiding staff through a “to do” checklist with…

• Visual action flags,
• Due dates and reminders,
• Pre-populated documents,
• A helpful contact directory, and
• Clear status updates and emails.

This process makes it simple for sites to move forward at a quick pace while sponsors and CROs benefit from…

• Faster timelines,
• Historically approved CTA and budget terms,
• A robust projection engine,
• Dynamically calculated timelines, and
• Real-time dashboards

Have it Your Way

DrugDev offers our site activation technology any way you need it…

SaaS Technology Site-facing workflow tools and secure document exchange for your internal team to improve efficiency, transparency, site satisfaction and timelines.

Fully-Outsourced Dedicated experts manage the complete site activation process on your behalf.

Hybrid Model In-sourced technology with

“Using DrugDev Spark, I was done with the contracting process in 24 hours. It took four weeks for a similar trial with a different organization! It was striking how easy it was to go through the entire process. When I had questions, they instantly responded. When I used their technology, it was intuitive. When I looked at the budget and contract, they were well structured. DrugDev Spark works, and it gets better and better each time I use it.” – Nancy Baker, Site Manager, Clinical Research Consulting.

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• Establish Clinical Sites

Help Industry With Clinical Trial Design

• Participate In Initial Industry-FDA Meetings
• Perform Patient Preference Studies
• Give Input On The Informed Consent Process

Site Selection

Your participation in choosing the site(s) for the clinical study can help mitigate patient risk and attract participants, as well as providing useful knowledge of day-to-day living and general practicalities to researchers. Geographic and travel information is vital to the site selection process. Researchers may also be unaware of certain travel barriers (motion sickness, frequent bathroom breaks) or issues of accessibility (no accessible transit available) that will affect your patient participation. 

• An established Center of Excellence Network can simplify the site selection process. 
• Areas where the target population lives and normally travels.
• Barriers travel may present.
• Special accommodations that may be needed at participating sites.
• It may be difficult for the patient’s partner, parents, or other family caregivers to maintain their jobs.
• If the family has children who are not participating in the study, the children’s daily care or school attendance may be affected.
• The participant or their family may be far from their support network. 
• Financial burden may increase if the participants medical insurance provider may not be willing to cover medical costs that occur outside the study protocol because the site is out of network.

Continue to Step 3 >