Study Design & Development
First, you must ensure that you are asking the right question(s) since everything else in the protocol will revolve around this. Then, the right study design and a comprehensive protocol are crucial. The preparation and development of case report forms, study material or an investigator meeting are additional items that contribute to the success of the study implementation.
With our experience in conducting real-world investigations, YOLARX offers you assistance for development or review of:
- Protocols & case report forms
- Formatting of protocols as per agency requirements
- Sample size calculation
- Statistical analysis plans
- Study materials & validated scales (licenses, translations, etc.)
- Data access
- Investigator meetings
Protocol and Case Report Forms
A protocol should be developed as one of the first steps in any research project, and the protocol should be amended and updated as needed throughout the course of the study. Especially, when studies are conducted as commitments to regulatory agencies, the study protocol must be appended to the risk management plan and agreed by the authorities prior to product approval. Hence, a detailed description of the methods, data sources, potential biases and methods of control, should be included in the protocol. Some agencies or payers also require specific protocol templates. Our protocols can withstand strict peer-review processes. We also use best practices such as the Guidelines for Good Pharmacoepidemiology Practices (ISPE) and ENCePP Guide of Methodological Standards, amongst
Additionally, in the case of field studies, case report forms (CRFs) should be prepared. It is a data
collection tool to support investigators and coordinators in capturing all protocol-required information. In order to maximize efficiency and quality of data collected, we develop electronic data capture (EDC) systems with integrated quality control and secure data transmission.
YOLARX’s highly experienced multi-disciplinary research team can provide valuable assistance in protocol and CRF development or review.
Statistical Analysis Plan
Before the start of the study, the creation of a statistical analysis plan (SAP) allows to detail the features of the analysis described in a study protocol as well as statistical methods. It also includes explicit guidance on programming and presentation of the tables, figures, and listings.
As a premium research team for state-of-the-art pharmacoepidemiology and real-world investigations, YOLARX develops or reviews SAPs to ensure that the study sponsor obtains the output they need for the study report and guarantees the unquestionable statistical and scientific validity of their study.
Our biostatisticians and scientific team have extensive experience in preparing and reviewing advanced biostatistics analysis. They have developed numerous SAPs and conducted cutting-edge analysis for many different study types in various therapeutic areas.
Our multi-disciplinary team can support you in the preparation and development of a wide range of study materials such as case report forms, participant study materials, registration cards and interview guides and questionnaires. We can also help you find validated questionnaires or scales that would measure the outcomes that you need. In some instances, scales may not exist or if they do, may not have been validated in the target population of interest. For example, generic scales for quality of life do not apply to cancer or Alzheimer’s disease patients. It may therefore be necessary to create and validate a scale. We have the psychometric expertise to develop and validate scales, by assessing their content and face validity, as well as responsiveness over time.
YOLARX can help you with the set up and coordination of investigator meetings to ensure effective patient enrollment and retention. We can also provide appropriate study conduct training for participating healthcare professionals.