Giant is a promising contract research organization, specializing in providing drug and healthcare products development services to pharmaceutical, biotechnology and healthcare industry.

We are technical professionals with experience of broad range in providing expert consulting services to health care industry clients. We are highly qualified in regulatory affairs, clinical and preclinical studies management, data management, scientific report generation, information research, technology assessment, and strategic planning.

We take pride in providing innovative resources and cost-effective services. Working closely with our clients to understand their objectives, our project teams generate solutions tailored to address their issues and goals. Our expertise in critical evaluation and organization of relevant research data provides significant added value. We are committed to quality, customized service, and protection of client confidentiality.

Our CRAs are professional, knowledgeable and experienced. Experience counts and shows-our CRAs have successfully monitored simplified outpatient studies as well as larger complex inpatient studies. From Phase I through Phase IV, our CRAs bring in high-quality, clean data quickly, to help ensure a fast database close. Ongoing training ensures that our CRAs stay on top of changes in global regulations and pharmaceutical practices.

The Regulatory Affairs staff assigned to your dedicated Project Team work to ensure the successful and timely submission of your product application. We become part of your team from onset of project to completion meeting global regulatory requirements. Our standard is strict adherence to regulatory requirements to facilitate an efficient and complete product submission to the agencies you select-anywhere in the world.

OUR VALUES
Quality-First
Developing a reputation for quality: delivering services and information that reaches or exceeds the quality standards demanded by customers, doctors, patients and regulatory authorities
Customer-Oriented
Building lasting customer relationships by focusing on customers' needs and striving to exceed their expectations through flexible, customer-oriented solutions
Integrity-Based
Acting with an unwavering commitment to business and scientific integrity; building trust through honest, ethical behavior; acting with respect for others;
Teamwork-Driven
Creating dynamic, talented teams that work locally and globally, communicate openly internally and externally, are passionate about and enjoy what they do

OUR STRENGTHS
Develop and implement strategies to achieve clear-cut clinical development plans, scientific clinical trials, successful marketing approvals.
Organize, manage, audit, and critically evaluate extensive preclinical and clinical data.

OUR SERVICES
J & T provides a number of integrated drug development services to further our clients' goals. Our staff of medical and regulatory professionals, and clinical research associates (CRAs) have academic, governmental, and industry experience.

We are a full-service CRO. We design, monitor, and manage all phases of clinical studies and provide regulatory, clinical data management, biostatistical, technology assessment, and medical/scientific writing services tailored to specific drug development programs.Giantstrategically plans, prepares, and submits regulatory filings to SDA. At Giant, project management teams are structured to fulfill each client's drug development needs.

We Provide:
Clinical Trial Management
AGiant project team is assembled to address each client's specific needs, focusing on cost-effective and timely procedures. From expert regulatory affairs professionals to experienced CRAs, a Giant team is prepared to assist with:
· Clinical Trial Strategy Planning
· Protocol/CRF/Informed Consent Design/Review
· Site Identification, Qualification, and Selection
· IRB/Ethics Documentation Preparation, Submission and Tracking
· Investigator and Initiation Meeting Planning and Organization
· Site Training & Education
· Site Monitoring (Pre-study, Initiation, Routine, Close-out)
· Investigator/Patient Retention Strategies
· Quality Assurance/GCP/ICH Compliance and Audits
· Biostatistics/Data Management

Regulatory Affairs
Our team of scientists—pharmacologists, and regulatory affairs professionals—work closely to develop and implement viable strategies to move projects from conception to approval.
· Regulatory Services for Clinical Investigation of Drugs
· Strategic Planning for Clinical Development
· Evaluate the successful possibility of registration
· Facilitating rapid amendment initiation
· Preparation, Submission, and Maintenance of INDs and DMFs
· SDA Meeting Planning and Participation
· Regulatory Review of Clinical Trial Reports, Including Final Reports

When you work with Giant, a dedicated team of members from every discipline manages your project from start to finish--you know the team, and they know you. Your project is their first priority, and you receive the personalized service you deserve.