Clinical Services

Gsap as CRO, provides a broad range of services covering the full study management environment designed to make your clinical trial a success.

Gsap has helped numerous clients successfully manage the transition from preclinical development through to clinical studies, enabling them to make effective and fast decisions about the safety and efficacy of their investigational product. Gsap has a considerable breadth of experience and knowledge in supporting clinical trials from First-in-Human trials through Proof-of-Concept to Post Marketing Studies for a wide range of pharmaceutical, biotechnology and medical device companies.

1

Study design and planning

We consider the planning phase of the study as critical to success. We have the expertise to analyze the study needs, understand study objectives, and build the appropriate infrastructure for the smooth conduct of the study.
2

Regulatory

We use our regulatory experience in the evaluation of best and worst-case scenarios. This is critical to attain both the best Helsinki committee outcomes; and reach the goals of the regulatory strategy. We provide study protocol(s), IB, and ICF development.
3

Site selection and monitoring

We provide site management expertise, perform pre-study visits to analyze the site’s potential and operational patient flow. We qualify the professional study team; monitor and oversee all aspects of the clinical trial, ensure adherence to the study protocol- as well as procedural and GCP compliance.
4

Finance and management

Aligned with your study budget, we will carefully analyze your study needs. We will assess with you relevant vendors ,sites and investigators to achieve study tasks and goals. We offer management of budget, payments, contracts execution and logistic overview in order to promise excellence study progresses.
5

Data management

Your study deserves quality in data capture & management. Electronic data capture (eCRF) is commonly considered a standard requirement. We provide database design, verification, validation and staff training with an affordable EDC (ISO 27001:2013 and ISO9001 certified with global online 24x7 data center).
6

QA and Audit

We offer a flexible range of medical writing services, (in accordance with relevant guidelines), plans and training material to ensure a high level of study execution. We offer auditing services for your sites, bioanalytical labs and other critical contractors to verify compliance with GCP, GLP and GMP regulations.
7

Files and Documentation

We will set up site files and your electronic Trial Master File to comply with applicable regulations and guidelines. This will be maintained throughout the conduct of the study and reconciled to provide a completed Trial Master File upon study closure.
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