Unicorn Healthcare Solution

Clinical Research Solution

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.

Global Partners & International Governance

  • All of our trial clinical trials are by strictly governed by our global partner Paddington Testing Co, Philadelphia.
  • Our global partners are actively conducting phase I-IV clinical trials in reputed organizations throughout the United States with excellent efficacy.
  • We have a dedicated team of Doctors, Researches & Management personals working as a team to provide the best clinical research.

Unicorn Services & CR facts

  • Quality Assurance
  • Medical Services
  • Clinical Trial Management
  • Clinical Data Management
  • Clinical Monitoring
  • Statistical Programming
  • Biostatistics
  • Medical Writing & Electronic  

  Publishing

  •  Globalization.
  •  Privacy.
  •  Data protection committee
  •  Participation Safety.
  •  Clinical Trial participation.
  •  Ethical Issue.
  •  Globalization white papers
  •  Drug Development Process
  •  CR Market
  •  Fact Sheets.
  •  Member / Partner Profiles.

Quality Assuarance

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:

                Quality assurance

                Well structured organization with highly qualified personnel

                Detailed Standard Operating Procedures (SOPs)               describing responsibilities and duties

                Regular audits

                System improvement and consultancy

Medical services

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:

  • Feasibility of your study
  • Protocol development
  • Medical support of project teams
  • Investigator recruitment
  • Patient recruitment
  • Medical review of coding
  • Ongoing safety review
  • 24/7 medical support
  • Medical review of clinical study reports
  • Medical expert opinion
  • Consultancy services
  • Organizing advisory boards

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.

Clinical trial management

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:

  • Setting up study-specific procedures and documents, such as:
  • Feasibility questionnaires
  • Site assessment and identification plan
  • Monitoring plan
  • Patient information leaflet and informed consent documents
  • Patient recruitment plan
  • Patient retention strategy
  • Trial master file (TMF) and tracking within the Unicorn database
  • Investigator Study File
  • Contract negotiation and implementation
  • Grant management
  • Clinical Trial Management System (CTMS)
  • Selection and coordination of:
  • Laboratories
  • Investigational medicinal product logistics
  • Data Monitoring Committee
  • Training for study specific-procedures and underlying regulatory requirements to all involved stakeholders
  • Coordination of all study-related activities in all participating countries and between all involved stakeholders
  • Organization of meetings, e.g. investigator meetings

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:

  • Regulatory and operational experience
  • Sound scientific and therapeutic background
  • Stable team members, especially important for long-term trials
  • Efficient communication flow capabilities
  • Exceptional organizational talents

Clinical Data Management

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:

  • CRF design
  • Database design and programming
  • Integration of data from other sources
  • Coding
  • Data validation
  • Status and tracking reports
  • Patient related outcomes
  • SAE reconciliation
  • Electronic Data Capture
  • Paper CRF studies

Clinical Monitoring

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:

  • Protect the rights, safety and well-being of your clinical trial subjects
  • Oversee the progress of your clinical trial
  • Support fast recruitment
  • Ensure protocol compliance
  • Apply SOPs, GCP and applicable regulatory requirements
  • Ensure accurateness and reliability of clinical data
  • Help to increase acceptance of clinical data by the regulatory authorities

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:

  • Feasibility studies and concepts
  • Assessments of sites and investigator qualifications
  • Training of investigators and their teams
  • Ethics committee and regulatory authority submissions
  • Investigator Site File compilation and review
  • Translation of study-specific documents including quality check
  • GCP monitoring
  • Site management, including telephone monitoring and proactive issue handling
  • Study logistics support
  • Support for site audits and inspections
  • Preparation of investigator meetings
  • State-of-the-art study / project management, including risk management
  • Support of Data Monitoring Committees
  • Intensive training sessions during investigator meetings
  • Supporting analysis on data quality and timeliness as well as on individual investigational site performance
  • Detailed working instructions (e.g. via e-mail or other communication)
  • Newsletters on trial progress or trial-specific topics 

Statistical Programming

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
Pharmacokinetics analysis
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. 

Biostatistics

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:

  • Early phase study
  • Pivotal study
  • Post-approval study

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:

  • Superiority
  • Non-inferiority
  • Equivalence

Unicorn  will identify a strategy that:

  • Complies with regulatory guidelines
  • Maximizes the chance of success
  • Supports your marketing strategies

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. 

Medical Writing & Electronic Publishing

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.

Quality documentation

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.

Responsive, professional service

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.

Globalization

  1. Our global partners represent a significant portion of the research infrastructure conducting clinical trials in developed countries like United states& Canada.
  2.  Their strategy is that an ever-increasing proportion of this researches to be performed outside the “established” markets of specific locations.
  3.  Globalization of drug development in clinical trials significantly speeds the development process, sometimes cutting the cycle in half. 

Privacy / Data Protection

  1. Unicorn works globally to ensure a balance between legitimate concerns over protecting the privacy of personal              health information and the needs of medical researchers.
  2.  Access to personal health information for research purposes, almost always in key-coded form and accompanied by contractual user agreements that prohibit re-identification, is essential to areas such as comparative       effectiveness, drug safety, pharmacoeconomics, and other types of health outcomes and epidemiological research. 

Data Protection Committee

  1. Our Data Protection and Privacy Committee is comprised of member company data protection and privacy professionals and leads the Association’s data protection and privacy     efforts. They monitors and responds to specific data protection & privacy regulatory issues.
  2.  This Committee engages in collaborative initiatives with public-private consortiums and other organizations, and meets regularly with biopharmaceutical leaders, regulators and data protection authorities, peer associations, academicgroups and other stakeholders. 

Promoting Participation Safety

  1. While providing a variety of services to biopharmaceutical clients, we have following core responsibilities:
  2.  To ensure the safety of research participants.
  3.  To ensure the integrity of research data.
  4.  Promoting the Good Clinical Practice guidelines for clinical trials.
  5.  Unicorn members take their responsibilities seriously andinfrastructures.
  6.  Invest heavily in clinical staff training, education and advanced equipment that not only facilitates

                clinical trials, but also expands access to                enhances the level of health care provided. 

Clinical Trial Participation

  1. Choosing to participate in a clinical trial is an important     personal decision.
  2.  In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.
  3. The following frequently asked questions provide detailed information about clinical trials.

**Clinical Trial Participant Area

Ethical Issue

  1. In the market of clinical trials are one of the most important concerns regarding patient's right & safety.
  2.  All of our clinical trials & research programs are strictly governed locally by the BMRC (Bangladesh Medical &  research councils).
  3.  Unicorn members works very delicately meeting up all the ethical points provided by the BMRC and conducts each study after being successfully approved by BMRC, so that every participants rights are valued.

Globalization white papers

  1. This report analyzes the current state of global clinical      research and the role that biopharmaceutical companies            and their clinical research organization (CRO) partners.
  2.  With the changing landscape for CROs, the report has     several key findings:

 

Global trials speed drug development

Research quality standards must be met worldwide.

Clinical research improves local economies.

Emerging market equals growth market

Drug Development Process

  1. Bringing a new drug or medical device to market can is     costly & time consuming.
  2.  Research, product development, and clinical trials involve not only the sponsor's staff, but regulators, physicians, academic researchers, and patients.
  3.  Throughout the process, information systems managers must maintain the flow of data between researchers and sponsors, as well as to the world's regulatory bodies.
  4. Specialists in preclinical evaluation, clinical trial design and implementation, and biologics production all play significant roles.
  5.  This lengthy, expensive, and complex process is broken                 into several stages –

 

                ●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.

CRO Market

  1. According to the independent Tufts Center for the Study of Drug Development, clinical trials conducted by CROs are completed an average of 30 percent more quickly than those conducted in-house resulting in time savings.
  2.  Approximately two-thirds of CRO business is from the pharmaceutical industry, 27 % from biotech & rest funded by the medical device, foundation and government sectors.
  3.  Approximately 50 %of CT are conducted in the USA, 30% in Europe and the remainder in Asia, Latin America, Africa and the Middle East. 

Member / Partner Profile

Paddington Testing Co, Philadelphia.

Philadelphia, PA
USA
215-563-7330
215-563-9405 (fax)
Paddingtest@yahoo.com
www.parishdermatology.com/