The future of clinical development
Proclintek is an innovative Contract Research Organization Dedicated to Supporting Ground-breaking Medical and Pharmaceutical Discovery
Our Mission
Our mission is to provide smart and innovative solutions to sponsors and sites enabling clinical trials to be conducted cost effectively, with the highest quality and speed while putting patient safety first and maintaining data integrity.
Our Vision
Proclintek is committed to providing world-class services in terms of meeting staffing needs as well as providing IT solutions that simplify the medical trial process. Our end goal is to attain operational excellence that brings real value to medical development programs.
Our Strengths
Proclintek is committed to providing world-class services in terms of meeting staffing needs as well as providing IT solutions that simplify the medical trial process. Our end goal is to attain operational excellence that brings real value to medical development programs.
- Highly skilled and qualitative resources.
- Advantage of Early Entry.
- Unique, Versatile, and State of the art products in Education, Health Care and Telecom.
- Flexible business models such as SaaS, Revenue Sharing and Managed Services.
About Us
Who We Are
We are the premier pharmacology and clinical research service provider that seeks to drive change in the industry through a forward-thinking approach that leverages innovative software.
We are focused on providing services in three key areas:
- End-to-end solutions in life science
- Staffing consulting services
- Clinical Data management services
Our broad range of pharmacology and clinical research services plays a key role in accelerating medical discovery and providing the necessary support from Phase I to monitoring post-FDA approval. We take pride in offering custom-made solutions that are critical to pharma, biotech, medical device, and government establishments.
Why Choose Us?
- We provide A-Z services under a single Umbrella.
- In- depth therapeutic experience in all major and narrow therapeutic areas.
- Highly experienced project management team
- Focused on details
- Cost effective, flexible and dependable services
- Commitment of quality
- Maintain timelines effectively
- Strategic Planning and communication
- Commitment to employee growth and retention
- Innovative Leadership
- Believes in being a research partner and not a vendor or contractor.
- Large pool of investigators all all therapeutic indications
- Having experience in almost every therapeutic indication including vaccine studies
About Us
Leading Provider Of Quality Clinical Research Services
Clinical Operation
Our clinical operations team is highly experienced and trained in effective site management services, ranging from feasibility study to study close-out. Collectively, the team has vast experiences in several therapeutic areas. We ensure the best clinical services, highest ethical standard and quality clinical data.
Project Management
At ProClinTek, we consider our success in the success of our Clients project. We work as a strategic partner to complement your team. We are experienced in the management of clinical studies in all phases I-IV, in all major therapeutic indications.
Site Management
A thorough feasibility and site selection is the basis of any successful clinical trial. Our feasibility group has worked on virtually every therapeutic area.Our study feasibility assessment process is efficient and is capable of identifying the best investigative sites to conduct a clinical trial.
Protocol Development
A well-designed set of Standard Operating Procedures (SOPs) can improve efficiency, lower costs, elevate compliance, clarify team roles, reduce training requirements, raise quality, improve safety, and enhance your ability to troubleshoot and correct problems.
Site Monitoring
We provides comprehensive site monitoring and management. Our Clinical Research Associates (CRAs) act as the liaison between the sites and the study team. Our CRAs are assigned to specific sites for the duration of the study to provide consistent support for sites. All monitoring activities are conducted in accordance with GCP/ICH Guidelines and follows FDA/EMEA regulations.
Regulatory Affairs
We support our client’s product development programs by playing a pivotal role in obtaining regulatory approvals in the shortest possible time. We have a dedicated in-house regulatory team which assists in a broad range of Regulatory Consultations for most effective approvals and strategies.
Data Management
Our primary goal in data management is to provide clean, locked databases, in a suitable format, on time and on budget. Clinical Data Management (CDM) team experts are committed to upholding a standardized, process-driven approach.
Pharmacovigilance
We offers pharmacovigilance solutions for clinical safety, post-market surveillance and risk management or risk minimization plans. Our Medical Affairs team is comprised of experienced clinical professionals who analyze the safety profile of their products throughout all the phases of clinical development and post-marketing.
Medical Writing & Translations
We support our client’s product development programs by playing a pivotal role in obtaining regulatory approvals in the shortest possible time. We have a dedicated in-house regulatory team which assists in a broad range of Regulatory Consultations for most effective approvals and strategies.
Quality Assurance
Quality Assurance includes all planned and systematic evaluations necessary to ensure that all quality requirements are fulfilled and that a trial is conducted, the data generated, documented (recorded) and reported in compliance with GCP and regulatory requirements
Bioanlytical
All assays and methods are validated according to US-FDA guidelines. In addition to providing support for in-house clinical pharmacology activities, our bioanalytical unit also routinely provides support for clinical studies conducted at other sites.
Observation & Non Interventional Studies
Non-Interventional Studies (NIS) are performed for approved drugs within the standard therapy. Usually, these studies are intended for the documentation of the use of a drug under “field conditions”, i.e. without the “experimental bias” of clinical studies.
THERAPEUTIC EXPERIENCE
Clinical Research Therapeutic Experience
We recognize one of the most important pieces of your outsourcing puzzle is a CRO’s therapeutic expertise. Our strong medical expertise and significant operating experience make us an ideal gateway and partner for your study. We have a vast experience in conducting clinical trials for pharma and biotechnology companies spanning all major therapeutic areas.
