Discover our solutions and expertise on eForm design and implementation:

e-CRF (electronic case report form)

The Case Report Form (CRF) is a specialised clinical research document. It should be study protocol driven, robust in content and have material to collect study-specific data. Though paper CRFs are still widely used, electronic CRFs (e-CRFS) are gaining popularity due to the advantages they offer, such as improved data quality, online discrepancy management and faster database lock, etc.

 

The setting up of a central database and an electronic collection form via the Internet called e-CRF meets these needs by combining technology, simplicity, privacy and data security. The use of an e-CRF can provide the means to aid and accelerate the implementation of clinical development programmes and significantly reduce the cost of the study and logistics.

 

The advantages of e-CRF vs. paper CRF:

  • Lighter logistics;
  • Optimisation of site visits by upstream preparation;
  • Better data input quality (upstream checking);
  • Privacy and security (password login, encrypted data , secure protocol);
  • Automated data entry control (automatic queries);
  • Centralised real-time quality control (indicators, display panels);
  • Secure automated randomisation with real-time alignment;
  • EIG alerts in real-time, deviance (by e-mail or SMS);
  • A high level of information shared by all participants in the study.

Health reported outcome

The voice of patients, consumers and healthcare professionals play a crucial role in research. Throughout the product lifecycle, data from health reported outcome measures provide an accepted source of evidence for product evaluation, approval, communication and marketing. Subjects involved in a research programme can become the protagonists of the study, by providing their real life observations.

 

SPRIM ADVANCED LIFE SCIENCES has a software suite called Health-Reported Outcome Digital Solutions that caters to this requirement. It has been successfully adopted in major research areas to support our activity.

 

According to institutional guidelines, we are able to develop electronic tools designed for strategic information collection from different subjects enrolled in a research programme:

Patient-reported outcome (ePRO)

is a measurement based on a report provided by the patient about the status their health condition, without the patient’s report being amended or interpreted by a clinician or anyone else.

Observer-reported outcome (eObsRO)

is a measurement based on an observation by someone other than the patient or a health professional. This may be a parent, spouse, or other non-clinical caregiver who is in a position to regularly observe and report on a specific aspect of the patient’s health.

Clinician-reported outcome (eClinRO)

is based on a report produced by a trained healthcare professional after observing a patient’s health condition. A ClinRO measure involves a clinical opinion or interpretation of observable signs, behaviours, or other physical manifestations deemed to be related to a disease or condition.

Performance outcome (ePerfO)

is a measurement based on a task performed by a patient (measures of gait speed, memory recall, or other cognitive tests) according to instructions that is administered by a healthcare professional. Performance outcomes require patient cooperation and motivation.

 

“We rely on digital and mobile tools for
data capture and collection:
discover our totally digital solution.”

Connected device

The rapid speed of progress in use and development of mobile and connected devices has opened up new avenues in health management, enabling people to take a more active role in looking after their health and well-being.

 

We believe in technological and digital innovation. We can integrate our research programme with data from different sources, such as mobile technology, by using a tool designed for smartphones or tablets. We can also integrate connected devices to improve recording, monitoring and sharing of health information.

 

Data collection directly from patient or consumer can have a positive impact on health management only if it is carried out with validated tools and enhances the value of big data collection. We can plan a research programme to validate and improve the data collection tool and integrate connected devices.
Learn more about our service:

  • Device usability and satisfaction implementation;
  • Device performance validation in comparison between gold standard;
  • Research data implementation tools to collect data remotely and through the use of unconventional sources, such as audio, video and photos;
  • Science-based smartphone applications development through technical and IT consultancy.

 

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Computer assisted solution

These tools are generally used in the consumer research arena. They are based on different media usage, and selected in accordance with the study’s objective. We can design a research programme based on a different computer-assisted solution to meet our customer’s requirements:

CATI:
for your telephone surveys

CATI is a Computer Assisted Telephone Interview. This service is supported by a specific software able to make calls, generally conducted by an operator. It offers real-time monitoring, which can provide a full vision of survey trends; it even comes with a remote control.

CAWI:
for your web surveys

CAWI is a Computer-Assisted Web Interviewing device. The use of a fully computerised system allows you to collect and monitor real life data. Questionnaire answers are immediately sent to a server that provides ongoing data monitoring and control.

CAPI:
for your face to face survey

CAPI is a face-to-face survey. Data collection is generally made easier by the use of portable devices that can facilitate the interview. The service is administered with the support of a computer media solution, such as notebooks, netbooks, tablets and smartphones.

CAMI:
for your mobile interview

CAMI is a Computer Assisted Mobile Interview. Prevalence of mobile phone usage has changed the future of research. Mobile phones provide access to valuable information and tools such as geographical location, internet access, SMS messages or emails and multimedia files.