Sponsors/CROs

 

If accelerating enrollment is one of your greatest needs, then it's time to put Clinical Site Services (CSSi)'s patient recruitment services to work for you. CSSi brings you solutions based on 14+ years of working with sites and identifying pathways to patients to educate and connect them to sites.

 

 

We have solutions to overcome all of the top enrollment challenges in the industry:

  1. Site Selection – Finding the right sites with the right patient population
  2. Patient Education - Development of effective educational patient-facing study communication
  3. Site Performance – We provide customized enrollment planning and services to engage and maximize enrollment at each site
  4. Patient Recruitment – We are a global full-service patient recruitment company with solutions for all studies
  5. Patient Retention – Technological solutions to educate, engage and communicate with study participants

For more information, click on the list of services we provide below:

 

Design, Development & Publication of Enrollment Tools

Enrollment planning starts with developing a cohesive study message. This messaging helps in keeping the study top-of-mind for study coordinators, makes the study easily recognizable for potential study participants, and increases the overall study visibility. CSSi develops the tools that sites need to effectively enroll subjects for this study.

Branding and Logo Design

A well-researched and developed study brand is the first step to setting the tone for any clinical trial recruitment campaign. CSSi develops powerful study and site brands to convey positive and meaningful messages to potential study participants. This is the foundation for all patient and physician facing materials, websites and advertisements used throughout the enrollment period.

A good branding strategy will achieve a number of key objectives:

  • Deliver a clear message
  • Connect with the target audience
  • Promote study and site awareness within the patient population
  • Increase site awareness of the study
  • Solidify patient and site loyalty
  • Utilize the newly designed logo throughout the branding strategy, marketing messages and retention program

Enrollment Tool Development

CSSi performs a thorough analysis prior to the creation of any marketing materials. We ask ourselves the following questions to determine the best enrollment strategies for each study we support:

  • How do the demographics and psychographics affect the message?
  • What is the potential subject's current attitudes and perceptions about participating in this clinical trial or clinical trials in general?
  • What are the recruitment challenges?
  • What will the potential study subjects gain by participating in this trial?
  • What tone should be utilized in communicating the information about the study?

CSSi's Recruitment Patient Awareness Kit (PAK)

This PAK can be customized to your study's needs, but a typical study PAK includes:

  • Study Brand and Logo
  • Pre-screening Pack
  • Informed Consent Flipchart
  • Pocket Protocol
  • Referral Kit and Cards
  • Flyer/Poster
  • Brochures
  • Banner/Easel
  • Press Release
  • Doctor-to-Patient Letter
CSSi Recrutment PAKs

 

Digital Media

CSSi utilizes a wide variety of highly targeted digital advertising. By placing ads within online groups, forums and specialized websites that are already formed and therapeutically specified, the impressions are viewed by patients that are already frequenting these information sources.

Our experienced media team plans, executes and optimizes campaigns to maximize enrollment results.

Digital Advertising

Google AdWords   Google

Advertising on Google and other search engines is an effective method for ads to appear beside relevant content. CSSi's Google-certified media team ensures our ads are triggered when users search by keywords or phrases related to their health condition, making this a highly targeted and invaluable vehicle.

Google Display Network

Advertising on the Google Display Network extends the message by having banner ad presence on websites that are Google partners. Campaigns are geo-targeted around the clinical study sites, minimizing media waste.

Social Media

Facebook is a social networking website whose mission is to give people the power to share and make the world more connected and open through various social groups. Facebook's ads are structured and targeted towards specific audiences using a variety of filters. Facebook differs from other internet-based advertising because of the amount of demographic information that is collected from each user. This form of social media is the most targeted form of advertising for our target audience. A relatively complete profile of a person or group's psychographic make-up is constructed, called a psychographic profile, throughout the Facebook experience that allows advertisers to target them with much better accuracy. This information includes a variety of factors including sex, age, education, political leanings, relationship status, interests, activities, opinions, and keywords. Ads can be purchased to target specific subsections of Facebook's user base. This ability to target consumers utilizing such comprehensive data has offered us the opportunity to focus on those who are most likely to participate in a clinical research trial

 

Access to large Patient Databases

We utilize digital health consumer databases; these communities serve as great access points to a wide variety of patients.

 

Local Enrollment Specialists

CSSi's team of Local Enrollment Specialists (LES) are focused on increasing site performance. They are local to their designated region, speak the native language, and are familiar with the regulatory environment. These individuals aid your site in overcoming the many challenges of patient recruitment by:

  • Executing successful, diverse patient recruitment services on time and on budget
  • Maintaining compliance with local ethics and regulatory approval processes
  • Ensuring that the cultural and language demands of working in diverse parts of the world are met
  • Identifying and executing the most efficient tactics by country, region and site
  • Providing "hands-on" and "feet-on-the-street" capabilities, achieving maximum study awareness
LES Team doing more

As former study coordinators themselves, our LESs understand a site's challenges and needs. We listen to the sites and create a custom enrollment plan to help each site meet and exceed its enrollment goals. On average, sites who utilize our LES support services have noticed a 50% increase in enrollment. To help take the burden off of the site, the LESs work to:

  • Develop and manage recruitment efforts
  • Conduct on-site chart reviews
  • Pre-screen patients before scheduling them for site visits
  • Develop a customized advertising plan
  • Network and form relationships with local, regional and national organizations and advocacy groups through our Community Awareness Program (CAP)
  • Identify medical professionals that will refer eligible study patients through our Physician Referral Network (PRN) service

 

Patient Retention

Patient retention is critical to a study's success. There are many challenges to keeping a patient engaged throughout a clinical research study which could result in delayed timelines in your enrollment.

Challenges with retaining patients include:

  • Keeping patients compliant with study activities such as completing diaries/ePROs, taking medicine, etc.
  • Making sure the patient/caregiver feels part of something important
  • Remembering their scheduled visit days
  • The expense and time of having to recruit replacement patients for those who drop out

CSSi develops retention programs to reduce the dropout rates, increase compliance, and minimize the workload of the study coordinator. Our programs ensure retention activities are completed and that there is reporting to demonstrate the successes and challenges within the program. CSSi designs unique retention strategies to support:

  • Visit/Study/Medication Reminders
  • Educational Support
  • Appreciation Communications

Patient Engagement Portal

CSSi's Patient Engagement Portal has been designed to keep patients engaged throughout the course of a clinical trial. We have developed this portal to minimize the dropout rates and workload of the study coordinator while, increasing patient compliance. A variety of suggested application features include:

Patient Engagement diagram

CSSi customizes each Patient Engagement Portal by researching the patient, analyzing the protocol and leaning on our past experience with studies in the same therapeutic area. This thorough understanding of patient, protocol and disease allows our team to identify and map out the most appropriate applications to offer throughout the trial.

 

Technology

MyClinicalTrial ID

CSSi’s MyClinicalTrial ID (MCT ID) transforms the way sites and patients are identified, trials are enrolled, and patients are engaged. This platform is unique in that it can be used during both site identification and patient recruitment:

  • ID Sites for Studies - Allows sponsors to assess validated patient counts, making qualified sites stand out during the feasibility process.
  • ID Patients to Recruit - Rapidly identifies eligible patients utilizing de-identified, real-time medical data compared against a protocol's I/E criteria. When paired with our Local Enrollment Specialist solution, this platform makes it easy and efficient for busy sites to accurately identify and recruit eligible patients.

This revolutionary patient recruitment technology offers many features and benefits:

  • Decreases money wasted on selecting unqualified sites
  • Ensures sites have protocol-specific patients
  • Maximizes patient enrollment

MCT ID was developed to lessen the impact of ineffectual sites on a study’s timeline and budget.

 

 

Phone and Online Pre-Screening Solutions

Screener Funnel image

CSSi's pre-screening technology is a proprietary solution that provides maximum recruitment potential and metrics to make informed decisions about your recruitment tactics. This tool offers three types of solutions via web, phone or SMS texting. All three solutions source calls from multiple recruitment tactics for effective planning, can be customized to handle multiple sites within a study, and capture potential participants’ information to pre-qualify them based on specific protocol inclusion/exclusion criteria.

All of our screeners can handle multiple protocols to triage responders to the most appropriate study. These tools are all Privacy Shield compliant.

Our phone and texting pre-screening features include:

  • A unique toll-free number
  • Answering 100% of calls 24 hours a day, 7 days a week
  • Transferring callers directly to the site for further screening and scheduling

Our online patient screening solution can be incorporated into branded study or site website or may be used as stand-alone tool.

 

Website Development

CSSi develops websites for our clients as a stand-alone service as well as part of a full-service program. Our websites are created to match the study’s branding and provide potential study subjects with the information needed to make informed decisions. In order to increase the visibility of the site, CSSi utilizes Search Engine Optimization (SEO) techniques throughout the design process.

CSSi Client Portal

CSSi developed an exclusive clinical trial data management tool to keep our clients informed of all recruitment activities and results. Our portal provides transparency down to the site level with real-time metrics and customized reporting, that gives our clients the information they need to make informed, strategic decisions throughout the study. It enables historical analysis for strategic planning of future campaigns.

  • Sponsors/CROs have access to real-time data and graphical representations of site performance, reasons for disqualification and screen failures, pre-qualified referral statuses, enrollment projections, communication results, and more.

 

Traditional Media

Traditional advertising is used mostly to augment a site’s patient recruitment efforts when the timeline is short or the site has already gone through their database of patients.

Site-Specific Media Planning, Buying and Management

All too often, patient recruitment vendors apply a “one-size-fits-all” approach to media planning and buying for any given study. CSSi understands the intricacies of media planning, buying and management for clinical studies from the initial research through the ongoing maintenance. Our experienced media team evaluates and maintains each campaign for efficiencies to maximize results with a cost-effective strategy.

Planning

CSSi's media team takes a strategic approach to ensure that your patient recruitment messages are seen by the audience you are seeking. The quantitative and qualitative research we conduct prior to initiating a campaign is critical; it helps define the right audience and the best programming or vehicles to elicit a response that will lead to patient screenings. Our historical metrics also help us make the strongest recommendations from day one of the launch. This is the planning we do for every single site, regardless of budget or goals.

Buying

Media buying for a clinical research study requires an approach, which is different from the norm. CSSi examines and questions every rating, demographic and price - for every single market. Then, we discuss the likelihood for response because even though a television program has high ratings doesn’t mean the audience will respond. Lastly, we firmly negotiate added value, which equals additional exposure for your study.

Management

CSSi's media team’s work does not end with the launch of a campaign. Political campaigns, weather events and news incidents have the potential to derail media placements. We go to great lengths to track the performance of what we create and build on achieved successes. Some patient recruitment vendors plan for one mode of action for multiple weeks of a campaign, while we plan week by week for each site in order to capitalize on the greatest efficiencies, responses and cost effectiveness.