In a highly fragmented industry, we are a small group of organisation with the capability and expertise to conduct clinical trials and development of healthcare projects on a local basis. We specialise in the strategic development, management and analysis of clinical research programs in Bangladesh. We have the operational flexibility to provide development services on a stand-alone basis or as part of an integrated “full service” solution.
Commitment to quality
Unicorn is committed to uncompromising quality in all areas of our business. We conduct projects and activities efficiently and in accordance with international quality standards, best practices and ethical principles to ensure that our clients and regulatory authorities are provided the best possible services and products.
The Unicorn Quality Management System
To comply with international quality standards, best practices & ethical principles, Unicorn designed a Quality Management System. This system ensures that all operations and projects adhere to regulatory requirements and guidelines.
The Unicorn Quality Management System consists of the following elements:
Well structured organization with highly qualified personnel
Detailed Standard Operating Procedures (SOPs) describing responsibilities and duties
System improvement and consultancy
Clinical research is a complex challenge and depends on scientific, regulatory and medical needs.
Unicorn’s Medical Services department provides expertise throughout all stages of your drug development lifecycle in all major therapeutic areas, including the development of medical devices.
Our medical experts (all MDs) provide advice and support for:
Our Medical Services team has long-standing experience in clinical research and understands the different medical requirements to conduct clinical trials in various parts of the world. Trials in oncology, neurology, psychiatry, dermatology and cardiology are major areas of our MD’s expertise, including experience with megatrials.
Excellence in execution
Clinical trials require the use of human subjects and can severely impact the safety and well-being of the participating subjects. Success or failure of clinical trials can also severely impact large amounts of capital. For those performing the trial, the proper management of clinical trials is crucial.
The clinical trial execution process at Unicorn involves coordinating people and resources, as well as integrating and performing all study-specific and needed activities in accordance with the study protocol and the project management plan.
Unicorn’s Clinical Trial Management services include:
When it comes to clinical trial execution, Unicorn offers a team of specialists that manage your trial efficiently, within compliance and on time. Unicorn Clinical Trial Management team has the expert qualifications you need to set up and execute your clinical trial, including:
When you choose Accovion’s Clinical Data Management services, you’ll benefit from a data management group with worldwide expertise and a reputation for excellence.
Accovion provides full data management services for all types of studies – medical devices, medicinal products and drugs – regardless of whether you’re conducting a small, single Phase I trial or multiple, complex Phase III trials.
Quality and flexibility
Our Data Management team ensures that your project is collecting and managing clinical data reliably, efficiently and in compliance with industry and government regulations. Unicorn Data Management services offer a maximum of flexibility for conducting trials with EDC, paper CRFs or a combination of both, on our systems or yours.
Unicorn can provide complete data management for your project or individual services as needed:
You want fast subject recruitment, compliant site performance and reliable data. You need efficient trial monitoring and well prepared clinical trial sites.
Monitors are the backbone of your clinical trial. Unicorn monitors:
Monitoring is a major cost factor in your clinical trial budget. Investing the money in an efficient monitoring service that considers the priority and complexity of your project without compromising quality is crucial for success. Unicorn helps you to find the right solutions and offers much more for your clinical trial, including:
An accurate, informative and easy-to-understand presentation of your clinical data, including complete traceability, depends on sophisticated statistical programming. Unicorn’s Statistical Programming services offer highly skilled programmers with extensive experience in:
Data preparation and programming of tables, listings, and graphs or figures
Data integration for pooled analysis
Data conversion and consulting
Regulatory submission support
Graphical patient profiles
Unicorn understands your needs and applies state-of-the-art industry practices to ensure regulatory compliance and facilitate regulatory review of your data. Unicorn’s thorough understanding of clinical data combined with efficient results in high-quality data presentation.
Unicorn’s Biostatistics team has a broad range of therapeutic experience and our statisticians hold advanced degrees. They have extensive knowledge of various designs, statistical methodology and global regulatory requirements and add value to your projects and support our organization with data-driven information, analysis, interpretation and study design.
Whether your study is:
We help you avoid needless complexity, errors and excessive cost.
Early proof-of-concept will be enabled by the use of innovative study designs (e.g. internal pilot studies or adaptive designs). Your study will be optimized with the selection of an appropriate statistical strategy for testing and parameter estimation.
Whatever your objectives are:
Unicorn will identify a strategy that:
Unicorn statisticians understand the balance between clinical science, sound methodology and financial constraints, and can determine a sample size to suit the questions you wish to answer.
We perform interim analyses to enable design adaptations and early decision making on critical development milestones, if required by your executive management.
Your product’s success depends on regulatory-compliant documentation that is well-structured, detailed and thoroughly accurate. You want skilled medical writers who are excellent team players able to respond to shifting timelines and changes in scope of work that characterize medical writing projects.
Unicorn medical writers create documentation covering a broad range of therapeutic areas in close cooperation with our Regulatory Consulting and Biostatistics services. Rigorous quality control standards ensure that your documents are accurate and easy to follow. Our medical writers can work independently or manage a team of writers and other professionals to produce low-, medium- or high-complexity documents for regulatory submissions and license maintenance.
Unicorn electronic publishing specialists can further enhance your documentation through electronic compilation and hyperlinking using the most up-to-date, industry-preferred software. You’ll receive concise and easy-to-comprehend submission-ready documents that are fully compliant with regulatory technical specifications and guidelines.
Your requirements are our first priority and we strive to provide a personally responsive, yet always professional, working partnership. Whether a single document or a full electronic submission, Unicorn delivers the quality documentation you need in a professional manner, on time and within your budget.
clinical trials, but also expands access to enhances the level of health care provided.
**Clinical Trial Participant Area
Global trials speed drug development
Research quality standards must be met worldwide.
Clinical research improves local economies.
Emerging market equals growth market
●Pre-clinical research - lasts one to three years and tests the drug in animals.
●If these tests indicate the product is safe, human clinical trials begin which consists of Phase I-IV clinical trials.