Clinical Trial Budget Preparation: Fill & Download for Free

Developing a clinical trial budget can be a confusing exercise for sponsors and CROs. There are too many cost variables to account for.This post covers the key cost drivers for medical device clinical trials. If you are a researcher or financial analyst working in clinical trial space or simply curious about clinical trial costs, this post will serve you well.So let’s get started.1. PATIENT GRANTPatient grant costs are broken down into screening, baseline and follow-up visits and medical imaging costs.A. SCREEN FAILURESClinical trial protocols have inclusion and exclusion criteria to qualify patients. Strict inclusions and exclusion criteria reduce the available patient pool for trial enrollment. Clinical sites spend physician and site coordinator time to screen for potential patients.During the budgeting process, map out the complete patient screening workflow. Speak with a few clinical sites to understand how many patients they would have to see in order to find one qualified patient. For example, a site may need to screen four patients to find one qualified patient. Understand how many hours the site is spending on screening activities and reimburse accordingly. It is not unusual to reimburse sites anywhere between $50 to $250+ per screen failure.B. BASELINE/INDEX PROCEDURE AND FOLLOW-UP VISITSDepending on the clinical trial design, data is collected at baseline/index procedures and follow-up visits. The site coordinator is generally responsible for entering the data in the case report form. Sites are reimbursed for the time spent to collect clinical trial data.Based on number and type data fields you are collecting, you’ll want to estimate the site coordinator time needed to collect and input trial data. Multiply the estimated coordinator time by the hourly bill rate to obtain the fair market value for each patient visit.In some cases, sponsors may choose to reimburse patients. Reimbursement for patients can include paying for their participation, reimbursement for travel, meals or overnight hotel stays.C. NON-STANDARD OF CARE TESTSMedical device trials may require non-standard of care tests such as medical imaging scans. These costs are generally not reimbursed by insurance companies or medical care agencies and should be budgeted as part of the clinical trial cost.D. PROCEDURE COSTSIf the clinical trial procedure is reimbursed, you don’t need to budget for the procedure cost. Insurance or medical care agencies will pay for the procedure. In case a brand new procedure where no reimbursement available, budget for the procedure costs.2. SITE COSTSA. START-UP FEESClinical sites spend significant time to initiate a new clinical trial. Sites are responsible for site specific informed consent development, Ethics Committee (EC)/ Investigational Review Board (IRB) submissions, staff training including participation in investigator/ site coordinator meetings and site initiation visits and execute a clinical trial contract. It is typical for sponsor to pay anywhere between $2000 – $5000+ in site start-up fees.B. EC/IRB FEESEC/IRB fees are in addition to site start-up fees. These fees cover the time spent to by EC/IRBs to plan and conduct review of the clinical trial protocol and other associated materials. Many EC/IRBs update and publish their rates annually.C. CLOSE-OUT FEESClose-out fees include time spent by site staff to reconcile clinical trial data, finances and regulatory documents during study closure. Not all sites require this payment but has started to become a more common practice in recent years.D. STORAGE FEESGovernment regulations require that clinical trial data be stored after study close-out. The duration for storage can range from 2-years to permanent storage. It is not uncommon for sites to have boxes of regulatory paperwork that needs to be stored once a clinical trial ends. The storage fees vary by country and site.Some sponsors make arrangements for site to send trial documents to an offsite storage location. Due to country specific regulations, a site might be unable to move documents outside their country.E. ADMINISTRATIVE OVERHEADClinical sites may require as much as 30% administrative overhead in addition to per patient grant amount. This cost covers management and legal resources needed to provide clinical research oversight and legal review of clinical contracts respectively.F. SITE MANAGEMENT ORGANIZATION (SMO)In certain countries such as Japan, data entry and collection tasks are outsourced to SMOs. For post approval studies, sites do not research coordinator support. Sponsors are expected to hire SMOs to support the site or pay the sites to hire their preferred SMOs.3. NON-PATIENT COSTSA. CLINICAL EVALUATION COMMITTEE (CEC)Adverse event and endpoint data is adjudicated by a non-biased, independent CEC. CEC is generally composed 3 or more physicians. CEC members review adverse events and trial endpoints in a team setting or independently.A sponsor can hire physicians to serve as the CEC and reimburse them at fair market value rates. It is more cost effective for sponsor to contract with physicians directly. However the sponsor has to assign its own resources to manage the CEC.The other option is for the sponsor to outsource management and conduct of CEC activities. This option is more expensive because you are hiring professionals to manage the CEC.CEC is a very important component of medical device clinical trial. Adjudicated adverse event data is highly regarded by regulatory agencies and the physician community. In many cases, it is a requirement to have adjudicated adverse event data in order to get the product on market.B. DATA SAFETY MONITORING BOARD (DSMB)DSMB is also known as the Data Monitoring Committee (DMC). According to IMARC research, the purpose of the DMC is to advise the sponsor on continuing safety of the trial subjects and those yet to be recruited and provide continuing validity and scientific merit of the study.For budgeting purposes, it is important to know that DSMB is required during trial enrollment phase and in some cases till all patients have reached their primary endpoint. The decision of whether or not to conduct DSMB meetings after the primary endpoint is reached, is up to the sponsor.C. PHYSICIAN CONSULTINGPhysicians are consulted during all phases of a clinical trial. Physician guidance is needed to develop clinical trial strategy, enrollment plan, final data analysis and publication plans.Depending on the physician’s medical expertise and geographical location, consulting costs can be anywhere between $150 – $600+ per hour. If a clinical trial is interesting to the physician, he or she may be willing to provide consulting services at no cost.D. INDEPENDENT CORELAB ANALYSISMany medical device trials collect imaging data such as angiograms, CT scans and X-Rays. Since this data comes from multiple sites, variability is expected. An independent corelab standardizes the collection and analysis of imaging data.Corelab costs can add up quickly. Costs depend upon the number of images analyzed per patient, the time it takes for the corelab to analyze the data, and the duration of the trial.Corelabs usually hire analysts to collect and calibrate data from different sites. The final analysis is usually done by a physician. Given the complexity of imaging data collection and analysis combined with the importance of corelab data to regulatory agencies, it is important that adequate and accurate budget is allocated for independent corelab analysis.E. MEDICAL DEVICE COSTOnce you are ready to enroll patients in the clinical trial, you’ll need to ship medical devices to the sites. Most sites will expect to receive these devices for free. The only exception is when conducting post approval trials for commercially available devices.Medical device manufacturers conduct trials for indication expansion. For example, a stent company may conduct a trial to get their heart stent approved for use in a different anatomy. For such expansion trials, sponsors may need to provide commercially available devices to sites at no cost.Whether or not you want to provide devices at no cost is a business decision. When investigational medical devices are provided at no cost, sites enroll faster and have a much stronger, collaborative relationship with the sponsor.4. LABOR COSTSIn order to conduct a clinical trial, you need to hire people that have expertise in clinical research and clinical trial management. Depending on the size of the trial and the number of trials conducted, resource allocations vary. Therefore amount of labor needed to run a study also varies.A. CLINICAL RESEARCH ASSISTANTS OR ASSOCIATES (CRAS)CRAs are primarily responsible for monitoring clinical trial data that is collected during the course of the study. They visit clinical research sites to ensure data is collected in a compliant manner.B. PROJECT MANAGER (ALSO KNOWN AS CLINICAL TRIAL MANAGER OR STUDY MANAGER)A project manager’s responsibilities can vary from one organization to another. Project managers are like “general contractors.” A project manager is responsible for managing the clinical trial budget, resources and timelines. The core function of a project manager is to resolve or escalate issues that come up during the course of a clinical study.C. DATA MANAGERA data manager’s job is to address data discrepancy issues by generating queries to sites. Data managers may also be responsible for implementing electronic data capture system or paper case report forms needed to collect trial data.D. SCIENTISTThe scientist is primarily responsible for developing the clinical strategy for a trial. Individuals with Ph.D. or M.D. degrees are usually the right fit for this role. In some organizations, the project manager also play the role of the scientist.E. BIOSTATISTICIANA biostatistician is responsible for developing a statistical analysis plan (SAP). The SAP documents on the data will be analyzed during the course of the study. A statistician or statistical programmer is also responsible for programming data tables that are incorporated in the final clinical study reports.F. QUALITYClinical research is a regulated industry. Quality plays an important role in ensuring sponsors, CROs, and clinical sites are conducting the trial in a compliant manner. A quality associate or manager helps an organization create and implement standard operating procedures (SOPs).Salaries for these roles can vary by geography and experience. The above list is not comprehensive. However it should give you an idea of the core resources needed to conduct a medical device clinical trial.5. SITE MANAGEMENTA. PRE-STUDY VISITSPrior to inviting any site to participate in a clinical trial, you want to conduct pre-study visit, also know as the site assessment visit. This visit becomes even more important if you don’t have any prior experience working with the site in a clinical or commercial setting.Although sites don’t charge for this visit, the sponsor will need to pay for travel and CRA labor costs.B. SITE INITIATION VISITS (SIV)Once the site has received Institutional Review Board (IRB) approval and the trial contract has been signed, it’s time to activate the site for patient enrollment.A SIV is conducted once you are ready to activate the site. SIV involves training the site on the clinical protocol and any other study-specific requirements.Similar to the a pre-study visit, the sponsor will need to pay for travel and CRA labor costs.C. MONITORINGOnce patients are enrolled in the study, you want to ensure data is collected in a compliance with regulations and the clinical study protocol. This is when monitoring comes into play.A CRA, sometimes known as the site monitor, visits clinical sites at regular intervals to ensure compliance.In recent years, due to push for reduction in clinical trial costs, several sponsors have started to monitor remotely rather than conducting an in-person monitoring trip.D. CLOSE-OUTOnce all patients at a site have completed their follow-up visits, it’s time to conduct a close-out visit. Any open items related to study conduct are addressed during the close-out visit.Although it’s always nice to have in-person close-out visits, it’s acceptable to close trials via remote close-out calls.6. MISCELLANEOUSA. INVESTIGATOR MEETINGSInvestigator Meetings usually serve to kick-off a new clinical trial. Investigators and research coordinators participating in the study are invited to participate in a 1-2 day meeting. The purpose of these meetings is to educate site personnel on the clinical trial protocol and any other specific trial requirements.These meetings can be quite expensive as airfare, hotel and meals are usually provided by the sponsor.B. TRAVELPlan and budget for adhoc travel. Since clinical trials are heavily regulated, you may need to visit a site to address a compliance issue or help them prepare for an audit. In other cases, you may want to visit a site to motivate them to enroll patients. Whatever the case may be, it’s always good to have some money set aside for travel.C. DOCUMENT TRANSLATIONSDocument translations costs can increase significantly depending on the countries in which the clinical trial is conducted. Sites where English is not the primary language, you may receive request for translation of key documents such as the protocol and site specific informed consent in the local language.Also if the adverse event source documents from non-English speaking sites are in their native language, additional costs will incur to translate documents into English for event adjudication purposes.D. TECHNOLOGY SOLUTIONSClinical Trial Management System (CTMS), Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), Interactive Voice/Web Response System are a few common technology solutions implemented when conducting a clinical study. These systems are needed to manage site contact information, collect clinical data and maintain clinical trial records. There is a monthly or annual license fee associated with these systems. Additionally staff is needed to manage and maintain these systems.E. REGULATORY FILING FEESRegulatory filing fees should not be overlooked as these can run into thousands of dollars. Depending on the class of medical device, different applications need to be filed with regulatory agencies, competent authorities and notified bodies.7. OTHER FACTORS:A. PROTOCOL AMENDMENTSDue to unforeseen circumstances, a clinical protocol amendment may be necessary. A protocol amendment has many downstream effects that can increase the cost of a clinical trial.A protocol amendment usually leads to additional IRB/EC fees, site costs, regulatory re-submissions and more.B. INFLATION, VALUE ADDED TAX (VAT) AND FOREIGN EXCHANGEInflation should be factored in for multi-year clinical trials. In the US, a minimum 3% inflation is expected.Sites in countries such as Australia and Europe, add VAT for the research services. VAT can be upwards of 12% on all research services.For trials conducted in multiple countries, paying attention to foreign exchange rates. At a minimum, annual review of exchange rates is advised. Clinical trial cost projections should be adjusted based on exchange rates.C. TRIAL ENROLLMENT DELAYSEnrolling in trials is tricky business. It takes longer to complete enrollment and initial projections are overly optimistic. Account for these delays when you develop your clinical trial budget.[1]To summarize, you should now have a solid understanding of these factors that impact clinical trial costs:Patient grant amount such as screen failure costs, data entry costs and travel reimbursementSite costs such as site start-up fees, EC/IRB fees, close-out and storage feesNon-patient costs such as core labatory fees, clinical events committee and data safety monitoring boardLabor costs – clinical research employee salaries or contractor paymentsSite management costs such as pre-study, site initiation, monitoring and close-out visitsMiscellaneous costs such as travel, technology solutions and regulatory filing costsOther factors such as value added tax, inflation, protocol amendment and delays in enrollmentFootnotes[1] Ultimate Guide to Clinical Trial Costs - Clinical Trial Podcast

The global clinical trial management system market crossed USD 1.6 billion in the recent years and is expected to continue growing during the forecast period. Rise in health concerns and increased R&D expenditure in life sciences& clinical research organization are likely to drive the market growth in the forthcoming period.The #clinicaltrialmanagementsystem industry witnesses several opportunities in form of availability of CTMS solution, rise in government funds for CROs. However, significant costs and dearth of healthcare professionals are likely to create major hindrance for the market growth during the forecast period. Overall, the clinical trial management system market is expected to grow at a CAGR of 12.1%.Request a Sample Copy of This Report:Clinical Trial Management System (CTMS) Market Size Report, 2025A clinical trial management system (CTMS) is tailor made software system to accomplish clinical trial data operations generated by pharmaceutical and biotechnological companies. A CTMS manages up-to-date clinical data initiation from planning of research proposal to preparation, conducting and reporting generation. Clinical trial management system performs planning on budgets, report budgeting, clinical data management and report generation and accordingly the requirements of recipient companies vary from the future prospect.The key players in the clinical trial management system industry include Forte Research Systems Inc., Bioclinica, Oracle Corporation, eClinForce Inc., Medidata Solutions, DATATRAK, Guger Technologies, PARAXEL International Corporation, and MedNet Solutions, Inc. Other participants include; ChemWare Inc., iWEb Technologies, Data MATRIX, Jade Global Solutions, Integrated Clinical Solutions, and MAJARO InfoSystems.

Company Level Budget:> Prepared usually in Nov/Dec for next FY, this is annual budget in which manager project planned spends and sales to arrive at number range.> This budget is important to give some kind of guidance to investors and set performance targets for HoD’s/P&L Managers.2. R&D Budget:> This is one of the important subsets of the overall budget, especially for R&D driven pharma firms in which they decide annual planned spends on R&D, clinical trials, etc.> This gives to R&D Managers & scientists to develop their work plan and devise timelines for discovery/development/filing which ultimately affects the launch of new products and financials.3. Commercial Budget:> This is again one of the important subsets of the overall budgets, here sales managers decide how much they wish to spend on sales & marketing activities to improve the sales of existing or new products. They also forecast annual/quarterly sales for the upcoming FY’which is then rolled up into the company budget through SBU level budgets.> Pharma firms usually perform ROI analysis to optimize the planned expenditures and then allocate these budgets. This type of budget is very important as sales is bread and butter of the firm.4. HR Budget:> This includes the cost of payrolls, new hiring, etc which is aligned with the strategy for next fiscal.