Full Service CRO

Patient centricity, remote monitoring, e-TMF, decentralized trials… A lot is taking place within the healthcare and pharmaceutical industry. Along the last 24 years, Sermes CRO has also evolved from being a traditional company to a new technology driven CRO. From the very protocol conception, we deliver tailor-made solutions that will partner you through the hole drug development cycle. Your organization can rely on our strategic scientific, clinical, and regulatory advice, supported by a strong business know-how.

More than 1800 clinical trials submitted in the last five years

Activities

Clinical Consultancy

Biostatistics and Data Management Unit

Quality Assurance Unit

Regulatory Unit

Pharmacovigilance

Contracts & Financial Unit

Monitoring Unit

Medical Writing

TMF & eTMF Unit

Clinical Consultancy

Sermes CRO’s 24 years of experience delivering clinical research solutions really make the difference for our clients. Based on our scientific and regulatory expertise, we deliver tailor-made consultancy solutions in all therapeutic areas. 

Our Clinical Consulting Unit takes care of helping our clients to develop the most efficient research strategy based on the objectives set. We ensure that our clients have the best possible strategy: cost-effective and in the shortest possible time.

One of our strengths is our demonstrated knowledge in the integral development of research in all its phases. Thanks to the internal development of our processes at all points, we can reduce times, which is essential for our customers when it comes to trusting us for their new launchings.

Inside our Consultancy Unit, we have created the Project Controller position. 

The Project Controller will act as a link between our consulting unit and the position of the traditional Project Manager and the Financial Controller.  This position will be the main point of contact in addition to accompanying the client throughout the development of the study.  The Project Controller will also be in charge of ensuring the economic management of the study in the most efficient way from the right beginning of the project.

– Development of clinical research strategy

– Clinical trial design

– Project controllers

Regulatory Unit

Accelerating trial’s approval is our reason of being. Sermes CRO is aware that conducting a clinical trial requires not only the correct scientific approach, but also effective regulatory strategies. Sermes CRO has a reliable regulatory expertise, delivering start-up solutions for more than 20 years. Your clinical goal is our goal; your regulatory compliance is our strength.

The flexibility, adaptability and problem-solving outlook of our team is our best way to ensure service quality. We are a trusted partner, working with top 10 pharmaceutical companies as well as biotechnology organizations and academia. We combine our deep regulatory knowledge – staying updated is key –with internal tools to speed-up your clinical trials. Only after analyzing your needs, can we set up with you the correct start-up strategy: submission process, contract managing with sites, among others:

  • CTIS & CTR related services
  • Patient reimbursement solutions: in-house developed application, in order to reduce management costs in clinical research.
  • EudraCT number application, XML preparation.
  • Insurance policy management.
  • Procedures with Institutional Ethics Committees, EMA, FDA, AEMPS (and European national agencies), Ministry of Environment…
  • Financial reports preparation
  • Contract management with sites, researchers and collaborating institutions
  • Payment solutions rates, site and researchers’ payment (any currency).
  • Registration and updates in global, European, and national clinical trial databases, such a ClinicalTrials.gov

The flexibility, adaptability and problem-solving outlook of our team is our best way to ensure service quality

Monitoring Unit

Following a strict monitoring method is critical when conducting a clinical trial. We will ensure ongoing patient’s safety, protocol compliance, data integrity, Good Clinical Practices and Regulation, throughout the lifecycle of your clinical trials. Our highly skilled team – composed of qualified staff graduated in Life Sciences – has extensive experience managing and monitoring clinical trials in almost all therapeutic areas, phases I to IV and other clinical researches such as non-interventional studies, medical devices, etc.

We make sure to conduct your trial complying with protocol requirements, SOPs, Good Clinical Practice (GCP) and regulations and quality assurance. In addition to working with pharmaceutical and biotech organizations, we have also specialized in partnering with independent researchers, academia, foundations, cooperative groups, and public institutions.

  • Feasibility and site selection
  • Investigator’s meeting planning
  • Pre-study, initiation, monitoring and close-out visits (Remote and on-site visits)
  • File management, study material, shipping, medication.
  • Project management (for both sites and sponsors).
  • Audit/inspection support and preparation.

Biostatistics and Data Management Unit

Our expert dedicated team is on-hand to provide accurate clinical data with a high quality data management and analysis process. A correct statistical and biometry approach from the very early protocol conception makes the difference when it comes to gather accurate conclusions. Furthermore, data consistency and proper data management is key to the whole lifecycle in your clinical trial. 

Our data management and biometry team are composed of Professors, statisticians, data managers and data reviewers. Our Biometry team is specialized in healthcare data and creation or review of scientific publications. Our number one priority is working for your organization as if it was ours, to take full advantage of data, making sure that the correct methodology and professional rigor are applied to every study. We are certain this is the only way to ensure efficient collection, management, and delivery of the highest quality data, to optimize your clinical trial development and data flows.

You can trust on our compliance of Good Clinical Practices (GCP), international and local regulations and, specially, data protection regulations (GDPR, HIPPA…), always guaranteeing the patient confidentiality and information.

Data management services:

  • Protocol consultancy and design 
  • Elaboration of Data Management Plan (DMP), and all associated documents like query plan (QP), annotated CRF…
  • Double 
  • Data entry and data review services
  • Management of queries, including communication and closures
  • Database creation and validation, both in electronic (eCRF) and paper form.
  • Generation of final datasets according to CDISC (SDTM and ADaM)
  • Medical Coding
  • AEs reconciliation
  • Data transfers, integrations, and customized data reports.

Biostatistics services:

  • Statistical Analysis plans (SAP)
  • Sample calculation (N)
  • Statistic consultancy 
  • Patient randomization according to the protocol requirements
  • Creation of interim clinical study report and Clinical Study Report (CSR).

Pharmacovigilance

Complying with both regional and global pharmacovigilance regulatory requirements is everyday work for our team. You can count on our professional healthcare staff and get pharmacovigilance solutions on time, and on budget. Drug safety management complexity may only be accomplished by ensuring the correct alignment between the own project, quality assurance, regulations and deadlines.

Interpretation, coding and reporting of any Serious Adverse Event or relevant safety information will be carried out by our team of experts.

We provide the following pharmacovigilance services:

  • Preparation of Safety Management Manual
  • Serious Adverse Event Management
  • MedDRA Coding
  • Notifications of Expected and Unexpected Serious Adverse Reactions in Eudravigilance database
  • Preparation and notification of Periodic Safety Update Reports (PSUR).
  • Preparation of safety reports

Medical Writing

Our team of scientific and medical writers will help you on the preparedness, elaboration, and advice of your clinical trial documentation. Sermes CRO’s Medical Writing Unit also delivers reviewing services for your in-house created documents. Take advantage of our expertise and knowledge on several therapeutic areas. 

Working closely with our clients is our day-to-day work. We analyze your needs and objectives to make sure we follow the established targets.

We deliver high quality documents on time, according to any project requirements:

  • Design and Creation of Protocol 
  • Product Dossier under Investigation (IMPD: Investigational Medicinal Product Dossier)
  • Researcher’s Manual (IB: Investigator’s Brochure)
  • Clinical Trial Protocol
  • Patient Information Sheet and Informed Consent
  • Diary and patient card
  • Final Clinical Report
  • Dossier of Scientific Consultation to Regulatory Agencies (SA)
  • Orphan Drug Designation Dossier (ODD)
  • Dossier of classification of advanced therapies drugs
  • Dossier for the Authorization of Voluntary Release of GMOs
  • GMO Voluntary Release Final Report
  • Registration Dossier (CTD)
  • Pediatric Research Plan (PIP)
  • Scientific publications: abstracts, posters, manuscripts, etc.

Quality Assurance Unit

We make sure that your clinical trials are conducted in a uniform and consistent manner, ensuring their compliance with Good Clinical Practices and regulatory requirements. Based on our extensive expertise, our team can help you right from the initial data collection to the final trial report. Our system: designing the project in such a way that each step of the clinical trial has a quality check component. Furthermore, we are internally committed to quality research. We annually audit projects, clinical trials, onsite audits, SOPs and processes. 

  • Audit preparation / support / implementation (documentation, site, laboratory…).
  • Process analysis and improvement.
  • Standard Operating Procedures (SOPs) preparation and review
  • Risk assessment of audit and inspection findings, as well as evaluation of implications for overall project quality
  • Development of Corrective and Preventive Actions (CAPA)
  • Comprehensive and effective training

Contracts & Financial Unit

Make sure to optimize your timings and improve your procedures when it comes to manage your clinical trial contracts, billing and payments. For more than a decade, we have been feeding our own in-house contract management tools, so now we are more than ready to help you in an efficient, qualified and compliant way. We can deliver a tailor-made solution for your clinical trial: just tell us about your requirements and we will adapt our service to your needs and give you advice on the best available legal clauses.

Are you looking for a competitive recruitment and your sites to be the first ones to include patients in your trials? We strongly believe that success is in the times of negotiation and signing of contracts.

Our experienced team can help you on:

  • Financial Reports Preparation
  • Contract strategy design
  • Clinical Trial Agreement management with sites, researchers and collaborating institutions
  • Legal advice on clinical research contracts
  • Specific documentation management (such as confidentiality agreements…)
  • Other contract management (data protection, remote monitoring…)
  • Payment scheduling, purchasing orders creation, invoice and payment requests.
  • Payment solutions rates, site and researchers’ payment (any currency).

TMF & eTMF Unit

Recording, managing, and storing all clinical trial information in a way that allows its accurate interpretation and verification is everyday work for our TMF team. More than 50 TMF specialists work in Sermes CRO filing documents from clinical trials all over the world – up to 50 countries for now. 

Be it a traditional paper TMF or an e-TMF project, we have the right people to perform the right work: on time, quality assured and complying with our client’s internal procedures as well as regulatory requirements. 

Our experienced team can provide your organization with the elaboration of TMF, Investigator Site File (ISF) and Pharmacy Site File (PSF). 

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