Ciruelo No. 19 Col. Ciudad Jardin, Del. Coyoacan, C.P. 04370. México, D.F. +52 (55) 5689-4390


Our
Solutions

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 can help you develop and bring your trial strategy and design to life through collaborative work with your team and our clinical and regulatory experts to ensure cost-effective results.
As time goes by clinical trials become more complex along with subject selection criteria, in a collaborative effort we can help you determine your trial’s feasibility and make the necessary adaptations in the design to ensure your study’s success.
Design and execution of pre-clinical trials, Phase I protocol development and execution, medical writing, monitoring, data management, biostatistics and clinical pharmacology.
From single site to multi-site and multi-national trials, we have the expertise to conduct your trials successfully.
Our team of experts will design a protocol that will meet all your clinical development needs for any phase of study.
Our clinical research associates receive expert training to ensure that your clinical trials are conducted in strict accordance with the protocol, GCPs and all applicable regulations.
Our team of regulatory experts will handle all regulatory procedures with Ethics Committees and Regulatory Authorities from study start up to study close out.
From contract and budget development and negotiations to execution
Our staff will take care of al requirements for AE and SAE reporting to Ethics Committees and regulatory authorities, as well as annual safety, final reports and DSURs
Selecting the right sites is essential to your study’s success. We will assess a study site’s abilities to conduct your trial and recruit patients to meet enrollment goals to insure the best sites are selected. We will conduct and document training on all study procedures (protocol, SOPs, IP management, laboratory, imaging, etc.) so that when the sites are activated they’ll be ready for first patient in. selecting the right investigative sites is one of the most important factors in successfully completing a clinical trial..
We develop tailored recruitment strategies to meet your study’s needs
Our flexible project management methodology is focused on quality, efficiency and communication. With senior management oversight we make sure that all issues and risks are quickly identified and managed.
We have an array of clinical and analytical sites that can conduct your bioequivalence trials and provide the most accurate results for you generic products.

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.



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