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What We Do 2017-08-18T09:30:43+00:00

Pre-trial Services

Inefficient patient-recruitment processes are increasingly a formidable barrier to pharmaceutical companies’ success in launching new products. With the fragmented nature of healthcare systems, eligible and willing patients are simply not being reached by the message that clinical-research opportunities are available to them.

Breaking down knowledge and access barriers empowers patients to self-refer to clinical trials. This lies at the core of our approach. Delivering consistency and supporting all aspects of patient recruitment, we offer a broad range of initiatives to complement and catalyse existing strategies, delivering motivated patients to the sites of your choice.

Marketing Outreach

“Our expertise is founded on many thousands of conversations with volunteers.”

One Research offers a full range of marketing outreach to recruit volunteers for all phases of clinical research.

Our multimedia marketing suite has been developed empirically to engage a diversity of patients, or specific target groups. One Research will implement a strategy that offers volunteers a clear pathway to research. We can design campaigns for specific trials or localities, or manage broader initiatives to support disease-specific cohorts of patients and portfolios of trials.

Our expertise is founded on many thousands of conversations with volunteers. We will deploy the most effective and appropriate media for your target audience. When patients are introduced to research opportunities through our marketing, we ensure that their first point of contact is positive and supportive. This builds trust, which impacts strongly on enrolment and retention rates.

Advocacy Group Outreach

“Patient-advocacy groups can be a powerful ally in the search for volunteers.”

Building relationships with advocacy groups is an integral part of patient-centric clinical-research recruitment.

Patient-advocacy groups can be a powerful ally in the search for volunteers. Working closely with appropriate organisations, One Research promotes the value of your studies and establishes trust with patients. Effective marketing doesn’t just flag opportunities to volunteers, it also provides the foundation for future relationships.

Social media and digital marketing can be integrated with more traditional communication to engage advocacy groups. These organisations take an active interest in highlighting the importance of research. They are ideal partners in developing long-term recruitment strategies such as disease-specific cohorts, or equally valuable supporting quick-response recruitment for individual studies.

Cohort Building

“One Research will help you prevent costly delays and start your trials on time.”

A cohort of screened and committed volunteers supports rapid patient recruitment for your clinical-research portfolio.

One Research will help you prevent costly delays and start your trials on time by building a cohort of patients to support multiple clinical trials. Instead of starting recruitment when the protocol is approved, a cohort provides a pool of screened and committed volunteers available from the earliest stages of trial planning. From feasibility through to post-market outcome studies, a cohort underpins every stage of your research.

A continuous dialogue with volunteers lies at the heart of the cohort approach. One Research speaks to each volunteer individually as part of the initial eligibility screening. We manage the ongoing relationship with update calls, study-match confirmation, first-office visits and patient-reported outcomes (PROs).

This dialogue lies at the heart of patient-centricity. It dramatically reduces attrition by keeping volunteers informed and engaged. Similarly, feedback can be passed to sites, CROs and sponsors in real time. Healthcare professionals are freed up to focus on their clinical duties because One Research becomes the communication hub for all stakeholders.

The cohort gives sponsors or CROs significant leverage when negotiating for the services of potential research sites because the provision of a large pool of screened patients makes the recruitment of volunteers considerably easier for site staff. This has proved to be an important differentiator when particular sites or investigators are in demand from competing entities.

Database Construction and Management

“A cohort database will allow rapid analysis of patient records according to geographical, medical and demographic criteria.”

One Research can design, build and manage a database specific to your patient-recruitment requirements – a resource for patients, sites, CROs and sponsors.

When a pool of patients is recruited for clinical research, their data must be kept secure, up to date and accessible to appropriate stakeholders. One Research can construct and manage a bespoke database designed specifically for the efficient running of clinical-research recruitment programmes. The database allows patient records to be kept up to date with options for email, text message and phone contact. It serves as a communication hub that centralises key information.

In conducting feasibility studies, a cohort database will allow rapid analysis of patient records according to geographical, medical and demographic criteria. Your choice of search functions can be included in the system, allowing you to identify sub groups and trends as needed. As patients progress through your research programme, linear data is captured. You have a valuable information resource for PROs and post-market follow-up. Ongoing hosting and management of the database is included in the package.

In-trial Services

For researchers, the science of the clinical trial is of primary importance. Patients’ concerns, however, are different and diverse. A failure to address those concerns will have a significant impact on recruitment and retention. A one-size-fits-all approach risks leaving some patients feeling unappreciated or alienated.

Our experience has shown that consistent contact with participants can have a hugely positive effect on both recruitment and retention. Patients and sites are supported through direct dialogue to ensure that their requisite needs are being met at all stages of research delivery.

Trial Rescues

“We can target specific areas, regions or countries, as required.”

One Research provides swift feedback and support either when patients are needed to ensure a clinical trial meets its recruitment deadline, or when attrition rates reach critical points.

Implementing fast and targeted marketing can increase patient recruitment when a clinical trial is compromised by a low number of volunteers or a high number of dropouts. Perhaps certain sites are struggling to find participants. We can target specific areas, regions or countries, as required. By engaging patients who have positively opted in, we ensure recruitment rates go up and attrition rates drop. At the same time, the administrative burden is reduced for your staff.

One Research also specialises in contacting research clinicians to garner feedback. Which initiatives are working to retain and engage patients, and which aren’t? Across multiple sites in different countries, we can give sponsors and CROs the chance to make evidence-based changes to their recruitment and retention strategy.

International and Multisite Support

“Wherever your patient populations are, we can access, screen and support them through a consistent recruitment process.”

One Research’s multilingual capability offers consistent communication across multiple sites and national borders – all from one central location.

The One Research model is perfectly designed to scale to multiple sites nationally and internationally. Wherever your patient populations are, we can access, screen and support them through a consistent recruitment process. We employ native speakers to ensure that communication with every patient is professional and positive throughout the research programme.

Similarly, we can establish dialogue with healthcare professionals (HCPs) at site level across national borders. From one central location, One Research takes responsibility for communication with clinicians and patients alike. Your team is relieved of the administrative burden and then free to focus on your research. Our support has a catalysing effect across sites, helping them meet deadlines and hit targets

Pharmacovigilance

“Dialogue lies at the heart of patient-centricity; it is a core part of One Research’s work.”

One Research provides full safety reporting, quality control and reconciliation to comply with pharmacovigilance regulations.

As part of our daily interaction with the public, we operate a full in-house reporting and reconciliation process. All safety information and adverse event reports are quickly and effectively managed. Our process is designed to integrate with your own reporting obligations. One Research can adapt its safety reporting to meet differing national requirements, ensuring compliance across international multisite trials.

Pharmacovigilance exists for the protection of the public, but terminology such as ‘safety information’ and ‘adverse event’ can have negative connotations for them. Dialogue lies at the heart of patient-centricity; it is a core part of One Research’s work. We are well versed in ensuring that safety reports are managed not only in accordance with regulatory requirements, but also in a way that maintains the confidence of trial participants.

Lost to Follow-up

“The sooner patients are contacted, the less likely they are to be lost.”

Re-establishing contact with patients who are deemed lost to follow-up can provide data critical to the outcome of your research.

Dialogue with patients is not only an effective means to pre-empt attrition from clinical trials, but it’s also a possible way to re-contact patients deemed lost to follow-up. One Research has built into its recruitment and retention strategies multiple stages to keep patients engaged. We can also include a ‘missed appointment’ follow-up call to contact patients before they are permanently lost from a clinical study.

The sooner patients are contacted, the less likely they are to be lost. One Research relieves sites of the administrative burden to keep attrition rates low. Where a group of patients are already lost to follow-up, One Research can mount a campaign to establish their status, contact them and retrieve medical information as required. The cost of recruiting new volunteers is five times that of keeping patients in studies. One Research offers sponsors, CROs and sites the means to retain or retrieve volunteers who are vital to the success of the study.

Post-market Services

Healthcare systems globally need evidence on which to base their clinical, management and policy decisions. Given the pressures placed on healthcare systems, there is an increasing need to translate interventions of proven efficacy in research settings into routine clinical care. Ultimately, this can have important consequences on real-world use, safety of medication and adherence.

Many initiatives aimed at collating such evidence fail to engage sufficiently with patients. This negates their real-world experience, resulting in unnecessary attrition and inaccurate reporting. Without listening to patients it is difficult to assume an understanding of their experience. One Research uncovers the narratives that lie behind the patient data, providing researchers with unparalleled and unique perspectives.

Outcome Research

“Dialogue lies at the heart of patient-centricity: reduced attrition rates are the consequence of a willingness to talk to research participants.”

One Research engages seamlessly with HCPs and patients locally or across national boundaries to support outcome studies.

Post-market studies are particularly vulnerable to attrition because of the scale and duration of the research. Patient motivation is a key component, especially if the treatments are available elsewhere. To support patients in the study, One Research communicates directly with them to identify problems; similarly, we can contact research clinicians, across national boundaries if required, to identify initiatives that are working well to retain patients. This information can be fed back to sponsors or CROs so that corrective action can be taken quickly and effectively.

Critical to One Research’s capability are our multilingual capacity and our focus on direct dialogue. Talking to researchers and patients in their native language is the best way to understand the challenges facing them during a long study. The dialogue itself forms an essential part of maintaining the relationship with participants, reminding them that they are valued, giving them feedback to maintain a sense of involvement. Dialogue lies at the heart of patient-centricity: reduced attrition rates are the consequence of a willingness to talk to research participants.

Patient-reported Outcomes

“Our ability to cross national borders, employing native speakers, means far-reaching programmes are easily managed.”

Specialising in direct dialogue with patients, One Research is the ideal partner to deliver real-world data for your PRO studies.

Patient engagement needn’t end with recruitment. One Research specialises in building cohorts of patients to sustain portfolios of clinical trials. These pools of volunteers are regularly spoken to as part of the relationship management process, and to keep information up to date. Cohorts are prime resources for conducting PRO studies, and direct dialogue is the most productive way to engage participants.

Equally, One Research can conduct PROs using data sources of your choice – perhaps a pool of patients already integral to your clinical research. Our ability to cross national borders, employing native speakers, means far-reaching programmes are easily managed. Working from a central location, consistent communication of the highest standard can bring vital new insights to support your research.

HCP Clinical-trial Support

Often, the burden of recruitment is placed on investigators and research sites, which are selected on their ability to recruit the desired patient population. Frontline clinicians, whether from the research or primary-care community, are frequently not being supported with the resources that they need to engage effectively with patients before or during a trial.

One Research can identify and provide localised physician support to help free up valuable resources. Whilst specialising in the fostering of relationships with patients outside of traditional clinical settings, we recognise too that a patient’s relationship with their physician can be pivotal in both their decision to take part and then stay in a study.

Physician Outreach

“Costly delays to your research, further down the pipeline, can be avoided”

One Research can identify and contact physicians interested in contributing to the recruitment of clinical-trial participants.

One Research conducts campaigns, internationally if needed, to identify referring physicians for your research. These campaigns are twofold: firstly, we will draw up a list of the most suitable physicians; secondly, we will speak directly to them to establish their level of interest in referring patients to the study.

This early-stage research also has the potential to unlock new sites near to the patient populations you are looking for – particularly useful for rare diseases. Costly delays to your research, further down the pipeline, can be avoided. Similarly, engaging in dialogue with potential referring physicians early in the planning stage gives you the best chance of selecting those most likely to make a success of your recruitment.

Nursing Support

“It is far more cost-effective to help a CRA to deliver results from a site than risk its failure.”

Additional nursing support can be valuable in gathering clinical-research data through follow-up visits to patients or sites.

One Research can recruit and manage registered general or specialist nurses to support your clinical-study programme. For example, visits to patients may be needed if volunteers can’t attend the site. Or perhaps, as part of a lost to follow-up campaign, a nurse may be needed to visit patients to update medical details. One Research will coordinate this activity to relieve your team of the administrative burden.

Nursing staff can also be helpful in supporting sites with the set-up and delivery of a clinical study – panel mining and pre-screening, for example. It is far more cost-effective to help a clinical-research associate (CRA) to deliver results from a site than risk its failure. In all its service provision, One Research seeks to catalyse your existing investment.