We know that conducting clinical trials is a complex task and we know you expect solutions that will assure that study goals and timelines are met. That is why we provide a full range of cost-efficient tailored solutions country specific expertise that helps our clients run successful trials.
Our team works to develop strong relationships with the sites and sponsors that ensure successful study start-up, maintenance and closeout of with timely quality deliverables. We are characterized by our flexibility, honesty, openness and commitment to your projects, which we believe is what allows us to help you succeed.
Our key solutions include:
We understand the importance of a proper regulatory strategy from discovery to commercialization that is why we offer the necessary services to meet your demands:
Regulatory compliance consulting
Regulatory development strategy: identification and support for label and prescribing information content;
Regulatory strategy planning and development for all sections of INDs, CTAs, MAAs and NDAs
GMP and GLP compliance, due diligence assessment and compliance strategies
CMC collaborative consulting and comprehensive strategy services for small molecules and biologics.
Clinical trial and marketing authorization/drug registration submissions to regulatory authorities
Regulatory Authority Meeting strategy and support
IND, IMPD and annual reports
Post-approval support
Dossier review
Investigator Brochure development and review
Drug Importation
Our clinical and regulatory teams experience will help you transition from clinical trial to post-approval seamlessly.
We can offer you the solution you need with:
Phase IV and observational studies: In many cases in order to insure patient safety and to demonstrate effectiveness or comparative effectiveness and safety late phase studies and safety follow up are needed.
Observational studies and Phase IV studies can generate the needed evidence to meet long-term safety and effectiveness, as well as identify and support new indications and changes to label and prescribing information.
Risk management programs: Risk management plan (RMP) design, implementation and updates as well as risk evaluation and mitigation strategies (REMS) development to ensure that the benefits of your product outweigh its risks.
Pharmacovigilance and Technovigilance: We can help you meet all your Pharmacovigilance and Technovigilance regulatory obligations. Case receipt and processing, submission of expedited reports, safety report translations, PSURs, DSURs, annual safety reports, literature search, aggregate reporting and safety signal detection and analysis.
Medical Writing: Our writers will make certain that your documents are clear scientifically sound and meet all regulatory requirements.
We provide a full range of cost-effective flexible solutions to ensure accurate and verifiable data are provided to you on time.
From study biostatistical design to data analysis to study report we will guarantee that you will always be provided with reliable data.
Our data management services:
Database design
Data entry
Data Analysis and Review
Protocol design review
Statistical analysis plans
CRF design
Statistical consulting
Statistical and clinical study reports
Our independent QA team of experienced professionals can audit any part of the clinical development process (from early phases to post-approval) delving deep into detail to ensure that the quality you expect is met while ensuring compliance with GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice) and 21-CFR § 11 standards.
