|Through the use of our observational research studies, we help you to understand the product and brand environment by providing insights into the attitudes and behaviors of health influencers and a given population towards healthcare trends and by generating new medical evidence.|
Observational research is a type of correlational research method (non-experimental) in which a researcher observes ongoing behaviour. It is often the preferred approach in the social sciences and marketing sectors. This social research technique involves direct observation of people in their natural environment.
Well-designed observational studies can help you, your patients, regulators, and prescribers understand the real-world use, value, and safety of your products. Observational studies are also increasingly important for decision-making, due to the fact that risks and benefits, patient-centricity and comparative efficacy remain the industry’s driving themes.
SPRIM ADVANCED LIFE SCIENCES can set up observational studies in all disciplines of human health by providing information on “real world” use and practice. We can detect signs of specific product benefit and risk in the population at large, which helps with formulating hypotheses to be tested during subsequent experiments. This can provide part of the community-level data required to design more informative and pragmatic clinical trials and inform clinical practice.
In accordance with international guidelines, we are able to support the conduct of various types of observational studies:
- Cohort studies
- Case-Control Study
- Transversal Studies
Scientific surveys offer the opportunity to understand consumer habits and anticipate behaviour related to issues influencing the choice of your “non-regulated” product.
Collecting information directly from the consumer means listening to their actual needs; this can make the difference between a successful or a disappointing strategy. Rely on our valuable support and experience to conduct surveys focused on:
- understanding the habits and behaviour of your consumers and patients;
- collecting and evaluating opinions on products, services and brands;
- defining the degree of consumer/patient satisfaction;
- completing treatment model and compliance-related information with subjective data, and defining their impact;
- assessing the actual or perceived safety of your products.
Health interview survey
Health interview surveys provide estimates on a wide range of health topics. They generally collect information on health status and outcomes, health care access methods as well as common demographic indicators to give users the ability to examine behaviour and risk factors across the population and within population subgroups.
SPRIM ADVANCED LIFE SCIENCES can provide you with custom-made questionnaires or the specific tools to set up your personal interview to collect health information. We can also offer strategic support based on digital solutions in the field of computer assisted solutions and electronic data capture.
Real life evaluation and data collection
It is increasingly recognised that conclusions drawn from a traditional clinical research approach are not always enough to inform decision-making. Assessment of product value requires an understanding of its impact on current management in a practical and real life setting.
Real life evaluation provides opportunities to discover new products, to prioritise asset development and support decision-making and deliver more efficient and insightful trials. Real life evaluation provides a new and unique commercial model that delivers mutually beneficial partnerships between companies and the health system.
SPRIM ADVANCED LIFE SCIENCES can extract relevant real world data from existing health information sources; analyse them to provide research solutions that take into account the key factors influencing outcomes. We can collect data that demonstrates real world product value, safety and effectiveness and generates scientific evidence.
Discover how Real World evidence can create opportunities at different stages of the product development process:
Health reported outcome
The voice of the patient, consumer and healthcare professional is an important influencer in the research arena. Throughout the product lifecycle, data from Health Reported Outcome measures provide an accepted source of evidence for product evaluation, approval, communication and marketing.
According to institutional guidelines, we are able to develop tools designed for strategic information collection, from different subjects enrolled in a research program:
- Patient-reported outcome (PRO): 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 (ObsRO): 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 (ClinRO): 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 (PerfO): 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.
SPRIM ADVANCED LIFE SCIENCES believes in the use of technology as an essential tool to improve the quality of data collected. Our activity is underpinned by digital solutions for health reported outcome data collection with a goal to enhance the quality and quantity of real life data.
For SPRIM ADVANCED LIFE SCIENCES, Quality-of-Life (QoL) insurance and improvement are key elements to be pursued through research. Methodologies involving the use of quality-of-life patient outcomes in observational and interventional health studies are based on extensive and diverse research methods.
A wide range of Quality-of-Life parameters are continually updated to stay abreast of new trends and actual needs in the field of human health.
Our mission is:
- to provide professional assistance using our database of academic and professional researchers interested in QoL studies, with the aim of combining efforts and interests to enhance the field of QoL studies in different research areas;
- to interact with academic institutions (organisations, university hospitals, international associations, etc.) in scientific areas related to: product areas, clinical trial designs and full service appraisals of the QoL of general populations and specific groups (such as segments of diverse age group, neighbourhoods, nations, etc.);
- to promote better cooperation between stakeholders involved in QoL studies by developing superior QoL methodologies for various segment groups and improving the quality of intervention strategies and plans;
- to encourage cooperation with other organisations regarding QoL studies in order to create a group of international QoL researchers worldwide.
Self-perception assessments are evaluations based on subjective perceptions and observations on the use of a product. They are used to obtain feedback related to sensory stimulation or a past experience. They are also useful tools to explore the personality, skills, strengths and motivations of the consumer.
Through the implementation of specific investigations, we are able to analyse the subjective opinions and experiences of individuals and determine the behavioural drivers that lead to their preferences for certain products. This knowledge is required to guide critical product development and product promotion strategies.
The aim of these studies depends by the type of subjects recruited in the analysis:
- Consumers: to analyse product perception;
- Experienced staff: product sensory profile definition.
SPRIM ADVANCED LIFE SCIENCES has analysed the methods that underpin better understanding of worldwide consumer needs and satisfaction. Preferences and consumer habits keep changing; therefore, companies are required to re-evaluate their products and processes in order to meet the requirements of an increasingly demanding clientele.
The analysis of trends, hidden needs and consumer choices provides important information to aid with the definition, development or re-design of a product, package or concept.
We have developed a strategic “Sensitive Test System” to improve our customer’s brand reputation, credibility and value. Testing specialised capabilities and demonstrating the consumer’s subjective perception could make all the difference to product success.
FMCG producers may have the opportunity to adopt a pre-market and post-market based analysis to assess what consumers think about their product at various stages of development.
These methods include:
- Sensitive Tests
- Usability Tests
- Purchase tendency evaluation Tests
- Safety Tests
- Product /Communication Tests
- Delphi research
- Ethnographic Investigations
Burden of disease impact study
The increase in disease and disease-related consequences can significantly affect society: determining the behaviour of people, the structure of the health system and the decisions of the regulatory authorities. Hence there is a need for studies based on tangible, reliable and high-quality evidence.
Burden of disease is a modelling technique that combines multiple data sources to count and compare the total number of people affected by certain diseases and injuries in a population (accounting for fatal and non-fatal incidence). This method also relates disease burden to specific risk factors:
Incidence and prevalence analysis
Epidemiological indices like prevalence and incidence are frequently used as an epidemiological measure to assess how commonly a disease or a condition occurs in a population. These values provide the required data to quantify the impact of a pathological condition and related risk factors.
By establishing partnerships with strategic key opinion leaders and disease experts, we are able to access, collect and process data in order to conduct descriptive epidemiology studies and estimate disease prevalence and incidence.
With this information we aim to achieve the following key objectives:
- understand health parameters and disease frequency and distribution;
- understand health related events such as diseases, causes of death and risk factors description;
- understand comparisons between the age groups, and between populations;
- provide tools to be used at the global, national and local level to anticipate health trends.
Health economics studies
Health economics promote health through the study of healthcare providers, hospitals and clinics, managed care and public health promotion activities. Health economists apply the theories of production, efficiency, disparity, competition and regulation to provide the public and private sector with extensive information about the most efficient, cost-effective and equitable action.
These studies can promote policy that enhances economic and social well-being. They can also influence health industry decision making process and consumer choices. Furthermore, value, budget impact and cost effectiveness are crucial considerations for formulary acceptance and market access of the product.
SPRIM ADVANCED LIFE SCIENCES conducts research programmes in the field of health economics to estimate some of the main health economic indices:
- Cost-Effectiveness Analysis, CEA
- Cost-Minimization Analysis, CMA
- Cost-Utility Analysis, CUA
- Cost-Benefit Analysis, CBA
Disease economic and cost analysis data
We offer consultancy service to explore direct and indirect costs associated with a specific disease, providing strategic information on the cost/benefit ratio through data collection and analysis:
- pharma-epidemiology analysis;
- pharma-economic analysis;
- cost of illness;
- health technology assessment;
- educational projects.
Product economic analyses
The introduction of a new product on the market requires a full economic assessment by the competent authorities. Said evaluation should explain the product’s economic impact on the health system. High-quality scientific services are required to meet the growing demand of health authorities and support convincing evidence to substantiate the value of a product.
SPRIM ADVANCED LIFE SCIENCES is committed in client strategy support, optimizing the decision pricing strategy on product ensuring market access in many countries.
We are able to offer a 360° support approach to define recommendations for the introductory price of a product, through the implementation of targeted survey to identify:
- economic impact studies;
- market and competitors analysis;
- consumer opinion collection and ideal price identification in respect of expectations of costs.
Health influencer’s observation
Consumer health products are often consumed under medical opinion or supervision. Understanding the attitudes and behaviours of key influencers may be a strategic way to anticipate trends related to the opinions of healthcare professionals.
Sprim ADVANCED LIFE SCIENCES can conduct specific surveys directly addressed to healthcare professionals in order to identify and analyse their opinions, providing an overview of medical practices and patient recommendations related to our customers’ products.
Key Opinion Leaders (KOLs) are specialists in their chosen field. Their opinions are held in high regard by both their peers and the public at large. Key opinion leaders play an important role in marketing strategy at every stage of the product lifecycle.
SPRIM ADVANCED LIFE SCIENCES are experienced in KOL mapping and identification globally, nationally, regionally and locally. Connecting with these opinion leaders helps with designing a powerful and innovative research programme that predicts how a market will be shaped in the future. The contribution of KOLs can also help you develop products that meet the exact needs of your target customers.