program & protocol design
SOCAR’s scientific leaders are recognised globally as experts and can deliver a comprehensive, tailored program and protocol design for our partners. Our services include the development of protocol designs and study implementation strategies that are efficient, cost effective, workable and tailored to the requirements of each clinical research project.
Access to a network of academics and opinion leaders
Our partners benefit not just from SOCAR’s operational expertise, but also from our extensive worldwide network of academics, (clinical) scientists and world-renowned opinion leaders.
Identification of expert committees
We can assist our partners with the identification of and setup of expert committees thanks to our extensive network of world-renowned opinion leaders in varied specialties.
Organisation of brainstorming meetings with key opinion leaders
SOCAR can assist with the logistical and scientific organisation of brain storming meetings between our partners and key opinion leaders in addition to drafting the complete meeting report.
Extensive literature research
SOCAR’s experienced team can perform detailed and complex literature researches.
Planning and preparation of regulatory meetings
Together with our partners, we assist with the organisation and preparation of meetings with regulatory authorities.
Scientific and clinical research expertise and program support
Combining SOCAR’s clinical research expertise and experience with access to our key opinion leaders, we can support our partners develop their clinical research programs.
Organisation, set-up and management of study committees
We can support our partners with the identification of expert KOLs and set-up of the membership of the different committees – e.g. Steering, Data Safety Monitoring and Adjudication committees – for your research study. We have vast experience in the management of these committees for the lifecycle of a trial e.g. we act as liaison between KOLs and our partners, organise meetings, write the meeting reports…..
A well designed enrolment and randomisation process is crucial to the success of any clinical research study. SOCAR has the capability to develop and create either straight forward or complex randomisation lists in addition to implementing a large variety of randomisation schemes, methods and tools which include:
Randomisation ratios other than 1:1
Dynamic balancing (e.g. stratification, minimisation, adapted minimisation, block, cluster randomisation)
Single or multiple stratification criteria
Dose titration calculations
Web-based randomisation using e-SOCDATTM
In addition, our highly qualified statistical team can provide the following support:
Evaluation of existing protocols or publications
Perform simulations and ad-hoc analyses to investigate underlying assumptions or study results
Patient enrolment and randomisation
Biostatistics and SAS programming.
study treatment management
eSOCDATTM’s Interactive Response Technology (IRT) services effectively manage patient enrolment, randomisation, dosing, clinical supplies, data integrations, drug/device returns and drug/device reconciliation. We provide innovative solutions to support you in the proactive management of sites, patients, and clinical supplies and specialise in the design, development, validation, and management of Interactive Web Response Systems (IWRS) for Phase I-IV clinical trials.
Increased configurability – more configuration options enabling you to customise to your specific study requirements
Build shorter timelines - enabling you to get your study up and running quicker
Easy to use system - reducing burden for site staff
Self-serve options – enabling you to take control and manage processes including randomisation, drug management and device distribution
Clinical supply management tools - updating pack status, expiry date information, batch release, manual shipments and many more – tools that allow faster decision making and execution
Flexible system-generated notifications for real-time trial information
Dynamic visit data collection - intuitive data collection allowing for reduced system development time and data entry errors.
clinical operations & monitoring support
SOCAR’s experienced clinical operations team can assist with clinical operation activities and statistical / onsite monitoring support.