Active Trial Maintenance

Services > Active Trial Maintenance

Our Active Trial Maintenance
Services Include:

  • Research Revenue Cycle Management
  • Access to RealTime CTMS Lite
  • Trial Entry into CTMS (RealTime or existing CTMS)
  • Ongoing Budget and Contract Negotiation
  • Trial Specific Advertising (if included in sponsor budget)

Experienced Trial Maintenance.
Optimized Financial and Regulatory Performance.

GuideStar’s philosophy is to run research like a business. While we all have the same goal – helping patients – the bottom line remains that in order to maintain that goal today and in the future, sites must be financially viable. We believe ensuring the positive flow of funds from work performed on trials is essential for long-term financial stability and growth. As we work diligently to ensure service coordination, optimal reimbursements and research success, you can keep your focus on departmental growth, interdepartmental integrations, and most of all – your patients.

We offer a wide range of Active Trial Maintenance services and deliverables, including:

Click the items below to view additional details about our ATM Services

ATM Included Services:

Research Revenue Cycle Management

Once a trial is initiated, aggressive research revenue cycle management should begin. From ensuring all start-up funds are invoiced immediately and collected, to trial account reconciliation and profit/loss reporting, having a strong focus on managing finances throughout trials will result in positive cash flow and, ultimately, profitability. Proper finance metric reporting provided by GuideStar will also help provide opportunities for site growth and additional FTEs.

Access to RealTime CTMS Lite

RealTime CTMS provides quick, easy access to study or subject information, utilizing simple and intuitive navigations. With access to RealTime CTMS Lite, your site will be able to easily see all of your study financials in one place.  Your site will also have access to powerful reporting tools that will enable you to see everything from outstanding receivables and total accruals to your study financial aging.

Trial Entry into CTMS (RealTime or existing CTMS)

Once your budget and clinical trial agreement have been developed and negotiated, the next step is to enter your trial into your CTMS to start tracking subject activity.  This can be a cumbersome process which requires significant time and effort, even for tech-savvy research professionals.  GuideStar’s research finance experts will build your trial budget into your CTMS so you can focus on recruiting your first subject.

Ongoing Budget and Contract Negotiation

After your trial is activated, the necessity for renegotiation of your study budget and contract may occur. GuideStar will assist you in ascertaining when these should be negotiated and will complete them on your behalf, including screen failure ratios, pre-screening efforts due to challenging eligibility criteria, on-site and remote monitoring visits, defraying ongoing administrative financial burdens, etc.

Trial-specific advertising (if included in Sponsor budget)

GuideStar’s media buying agency, ClinEdge Engage, works with clinical research sites to ensure the farthest reach at the lowest cost. We can utilize sponsor advertising dollars to centrally run your recruitment strategies for each trial. We would work within the provided sponsor advertising budget and can employ a variety of tactics including but not limited to online advertisement, traditional advertisement, community engagement, and national patient database.

ATM Add-On Services:

Regulatory Amendment Processing

After the initial IRB approval, Sponsors often mandate Amendments, which require effort in the review, drafting, and submission process. During this time, you can rely on your dedicated team of experts at GuideStar to address and promptly process these, allowing you to internally focus on other aspects of clinical research, such as enrollment.

CTMS Implementation

CTMS implementation can be a tough, time-consuming task for research sites of any size.  Our team can evaluate your site to determine the best-fit CTMS, then help implement the system across your organization.  We will send a team of experts on-site to help train staff on best practices and work to develop SOPs for long-term use of the system.  Our team will also help input all historical data so that your site is set up for success with a new CTMS.

Patient Recruitment

Additional Trial Specific Advertising

Our customized patient recruitment and marketing services through sister company, ClinEdge, will aim to support your site with education and engagement of patients and caregivers in the local area. We will support the site in overcoming a number of unique marketing and recruitment challenges through several different tactics, including social media management, newsletters, collateral, and more.

 

Creative Design Services

GuideStar’s creative design services through sister company, ClinEdge, can enhance and optimize every aspect of your research site’s brand or marketing image, from website design to site branding to patient education materials. When working with sites, our design team takes careful consideration of the individual mindset and concerns of your target patients.

 

Patient Enrollment Specialists

Access to GuideStar’s experienced enrollment specialists through sister company, ClinEdge, will help build patient enrollment for your site by prescreening all leads from provided advertising tactics. We will also prescreen patients from your database and schedule those that pre-qualify for your specific study, and continue to help engage patients with reminders via text, phone, email or mobile applications.

Interested in Active Trial Maintenance? Let’s chat!