Direct-to-Patient Contact Management
Effective direct-to-patient services is often essential to the success of Late Phase studies. As a part of clinical trials and observational studies, REGISTRAT-MAPI is uniquely qualified to provide a global multilingual direct-to-patient service offering called ProClinca™, currently operating in 29 countries.
Distinctly organized as an independent structure within REGISTRAT-MAPI, ProClinica™ insures better control of particular biases and greater confidence in data collection. ProClinica is considered an independent and trustworthy third party by all study stakeholders including patients, health care providers (HCPs) and Health Authorities with regards to patient confidentiality.
Since its establishment in 2001, ProClinica™ has proven results for patient retention, minimization of lost to follow-up, and patient reported data quality. We provide proactive actions similar to a study nurse/ co-investigator role: collection of high-quality data directly from patients and facilities and continued follow-up of patients if they transition to new HCPs.
What is Direct-to-Patient Contact Management?
Management of contacts with subjects (or their relatives) in studies or disease management programs to ultimately optimize the study or program
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Performed independently from the Subjects’ HCPs and/or Investigators
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Uses different means of communication
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Collect Subjects’ reported data at source
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And/or provide information, assistance, or other services to the Subjects
ProClinica™ offers a variety of services
Our services can easily be combined and tailored to offer the best solution to meet the study needs and enhance its quality and efficiency.
From Me to You™ features direct and proactive collection of PRO data from patients in a multilingual and multi-channel environment (paper, telephone, web, IVRS, SMS). Methods of data collection can be used in any combination depending on the project requirements (i.e., nature of data, target population, study type, budget, countries).
Remind Me™ includes reminders of upcoming appointments for physicians and/or patients in multiple methods such as email, SMS, letter, fax, automated or personal phone message.
Help Me to™ provides a Patient Help Desk with information and assistance.
Organize My Tests™ provides organization and follow-up of tests and examinations required for a study in collaboration with health care professionals who have an established relationship with the patient (local laboratory, nurse, physician).
Refund Me™ provides centralized management of patient expenses and allowances according to a standardized process, which is simple and quick to set up, whether at a local or an international level.
Make my Treatment Easier™ involves home delivery of treatments for clinical trials with the possibility of administration by a local nurse.
Benefits include:
- Increased study acceptance by patients and physicians
- Time saving and reduced burden on investigators
- Assistance, de-dramatization, and proactive assessment help the patient to participate
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Very often a reliable an
d irreplaceable source of information
- The patient is the natural historian of his/her own illness
- Patient's life is changing over time, including the physicians they visit
- Improved compliance with the protocol, study methodology, and scheduled processes
- Robust study results including improved response rate, retention/withdrawals and lost to follow-up rates
- Optimization of patient recruitment
- More reliable PRO data including control of some evaluation biases, specifically confusion bias and patient selection bias, fewer missing and/or inconsistent data
- Original, simplified, efficient and cost-effective study designs
- Secured study organization and follow-up
Data Collection/Contact management
Depending on study requirements, REGISTRAT-MAPI can use multiple technologies to collect subject-reported data. Although proactive outbound telephone contact with patients is preferred, diverse methods including postal and online (either alone or combined) are recommended to optimize response rates.
ProClinica™ interviewers, in every contact platform, use a web-based Computer Assisted Telephone Interview (CATI) module in order to secure the assessment process and to ensure a safe and anonymous storage of the health data in a unique and centralized PRO database.
The contact information for the patients is kept in a secure, independent database maintained by the ProClinica™ team.
This contact management system is designed to streamline contact with patients with built in reminders, reports, and contact information. The system provides queues for interviewers, and facilitates contact with ePRO functionality to deliver scripted and branched questions, for each specific patient, in their native language (CATI module).
Process design and supervision of contacts ensure full compliance with methodology, ethics, deontology, personal data privacy, and professinoal secrecy. In addition to a set of dedicated SOPs and Work Instructions, a Patient Contact Management Plan is set up for each project.