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Clinical operations

Message from head of department

“We live in a fast-paced world where improvements in one field are quickly adapted to others.
New technologies developed in other fields have shaped the way we do and manage clinical trials today and will keep doing so in the future.”

Overview

over 20 years of experience
in clinical trials management

QualitecFarma® clients have access to fast, flexible, and full services led by our Clinical Operations Unit with over 20 years of experience.

Our Project Managers and Medical teams offer strategic advice in the planning and design of a Clinical Development Plan, acutely defining and designating the project’s primary objectives with the support of bibliographic research and the client’s requirements.

fully integrated R&D support
for Phase I to Phase IV clinical trials

From the development and adaptation of Study Protocols, Informed Consents or eCRFs, eTMFs, to their final configuration, as needed, through the initiation of a study, with key advice on feasibility studies and initial listings for the selection of centers and investigators, to monitoring, statistical results and final reports.

We offer global support to R&D projects with the highest quality standards in Phase I to Phase IV clinical trials in different therapeutic areas, either for drugs or medical devices.
Our clinical pharmacovigilance unit develops its activity both in projects fully managed by QualitecFarma and individually contracted in external projects.

Services

All types of clinical trials
and projects:

• Management of clinical trials Phase I to Phase IV
• Phase 0 Trials
• Translational trials
• Adaptive studies
• “Basket” and “Umbrella” trials
• Medicinal Products, Medical Devices
• Patient recruitment engagement
• Drug and study materials management
• Investigator Meetings

Clinical Trial Start Ups
 

• Site selection and feasibility
• Contract management with site and vendors
• Submission to Regulatory Authorities and follow up until approval
• Submission of amendments to Regulatory Authorities
• Investigator Payments
• Patient Payment
• eTMF

Data management
and biostatistics

• eCRF development
• Validation of eCRF
• Randomization
• Electronic Patient Reported Outcomes (ePRO)
• Centralized Monitoring
• Medical and Medication terminology coding
• Periodic reporting
• Statistical Analysis
• Interim and final Statistical report

Monitoring
 

• Initiation visits
• Monitoring Visits
• Close out visits
• Remote Monitoring
• Centalized Monitoring
• Site Management
• Notification and follow up of SAEs
• Investigator site file inspection readiness
• Site Staff Training
• Audits according to GCPs

Medical Writing /
Medical Monitoring

• Protocol Design and development
• IMP related document (IB, IMPD)
• Evaluation of SAE
• Final Study Report
• Articles
• Posters for congresses

Clinical pharmacovigilance

our Clinical Pharmacovigilance
solutions

Our clinical pharmacovigilance unit develops its activity both in projects managed entirely by QualitecFarma and individually contracted in external projects.

  • Responsible Person for EudraVigilance
  • Safety Database Management
  • Safety Management Plan
  • SAE management
  • DSUR development
  • DSUR submission to RA and PIs
  • SUSAR submission to RA and PIs
  • Periodic reconciliations
  • SUSAR Line Listings

Quality assurance

Message from head of department

“In drug development, it is critical to preserve the two main principles of ensuring patients’ safety and rights, and data reliability of the clinical and post-authorization processes.”

Overview

ICH/GCPs AND GVPs

Thanks to a well-structured Quality Department, we have a highly qualified GCP system in place, granting the implementation of quality assurance in all our studies.

Cohering to ICH/GCP and GVP with respect to local and international legislations and upholding the highest quality standards in all processes.

ISO 9001:2015
All the company business units are ISO9001/2015 certified from Regulatory, to Pharmacovigilance and as a master commitment with support and service to our sponsors and clients.

Quality Management System

We uphold Quality Management System (QMS) and Quality Assurance (QA) procedures as the prime pillars of our way of work.

Our commitment means that we believe in full compliance with quality as a starting and completion point to work with our clients.

Services

We offer

• Clinical Site Audits
• Vendor Audits
• QMS Audits
• TMF & eTMF Audits
• GVP Audits
• Software Validation
• Training Content Creation and Application
• Support for Inspection Readiness
• QMS Development and Implementation
• QA consulting
• Implementation and development of a GCP system

Pharmacovigilance

Message from head of department

“We believe that making pharmacovigilance a dynamic activity leads to it being an efficient service.”

Overview

Offering the best pharmacovigilance systems management

Maintaining trial integrity and post-marketing surveillance are tasks entrusted to our human pharmacovigilance experts. Our responsibilities further extend to providing support in veterinary pharmacovigilance.

We set up pharmacovigilance systems focused on evaluating and managing safety issues related to the benefit-risk balance of human medicines and veterinary medicinal products.

Updated to the latest GVPs, our pharmacovigilance services guarantee a detailed and in-depth covering of all the pharmacovigilance activities to comply with the requirements of international regulations.

“We care about your health and safety”

Pharmacovigilance is a shared responsibility between healthcare professionals and patients. All possible information about medicines must be shared to achieve their optimal utilization. Identifying known or unknown serious adverse reactions as quickly as possible will help prevent or reduce their frequency and severity.

Under the umbrella of the latest Human and Veterinary GVP regulations, our highly skilled and experienced staff provides a reliable and flexible pharmacovigilance service driven by the establishment of a systematized workflow based on Standard Operating Procedures (SOPs).

Services

Human Post-marketing
Pharmacovigilance Services

  • European QPPV.
  • Local PV contact in Spain.
  • Adverse reactions collection and management.
  • Electronic database management.
  • Individual case safety reports (ICSRs) reporting to EudraVigilance.
  • CIOMS and case narrative preparation.
  • PV 24/7 contact point for safety issues.
  • Global and Local literature search.
  • European and Spanish Regulatory portals Monitoring.
  • Preparation of Pharmacovigilance System Master File (PSMF) and pharmacovigilance agreements.
  • Signal detection & management.
  • Preparation and submission of periodic safety update reports (PSURs) and risk management plans (RMPs).
  • Medical information enquiries (MIRs) & product quality complaints (PQCs) collection and management.
  • Safety variations management.
  • and many more…
Looking for Clinical Pharmacovigilance services instead? Click here!

Veterinary Post-marketing
Pharmacovigilance Services

  • Qualified Person Responsible for
    Pharmacovigilance (QPPV).
  • Local Representative in Spain.
  • Adverse events collection and management.
  • Suspected adverse event reports (SAERs) reporting to
    EudraVigilance Veterinary.
  • Preparation of PSMF and Pharmacovigilance agreements.
  • PV 24/7 contact point for safety issues.
  • Global and Local literature search.
  • European and Spanish Regulatory portals Monitoring.
  • Non-medical, Internet and Digital Media monitoring.
  • Union Product Database (UPD) and IRIS platform support.
  • Signal detection, monitoring and management.
  • Preparation and submission of annual statements and signal assessment reports.
  • Veterinary medical information enquiries (VMIRs) & PQCs collection and management.
  • Safety variations management.
  • Overarching communication plan preparation.
  • and many more…

Regulatory affairs

Message from head of department

“Being in the middle of the registration process makes you understand why the pharmacist provides you with a booklet of information and provides first-hand information to answer all the how’s and why’s that you can share with family and friends.”

Overview

Granted Marketing Authorization Holder

Our strategies focus on time-saving and cost effectiveness from the early stages to market through reliable and well established worldwide Regulatory Intelligence, with an in-depth collaboration with experts in our clinical research team.

QualitecFarma® is a granted Marketing Authorization Holder, with the purpose of being a strategic partner of companies in registration procedures, navigating the complex and strict changing regulations.

Dossiers development

We have a broad experience in the development, evaluation, and management of dossiers in close cooperation with international Health Authorities.

The first Spanish company to introduce the NTA 2001 (CTD) requirements and now working with eCTD compilations of the latest standards.

Services

  • Global development of registration procedures
  • Marketing Authorization applications
  • eCTD dossier development and compilation
  • Marketing Authorization Transfer
  • Renewals and Variations Management
  • Translations
  • Legibility tests
  • Dossier audits
  • Increase of customer company profits by parallel dossier submission
  • R&D of new expert reports. Wide experts’ network
  • Regulatory support with medical devices, food supplements, and cosmetics
  • LoD emission (pre-assessment reports)
  • Regulatory due diligence in M&A processes
  • Establishment of new pharmaceutical companies. Quality summary and dossier
  • Promotional Materials
  • Trainings
  • and many more…

BUSINESS STRATEGIES

overview

Decision-making processes throughout the search for business opportunities starting from dossier development and up to strategic planning of international registration procedures till the launch of the medicine on the market, or from the in-licensing process until the effective marketing.

Market access

We further study, search, and select partners for our clients to establish synergies and strategic alliances.

We pursue agreements that represent an improvement in the portfolio or in the turnover of the parts while trying to broaden the concept of licensing-in-out of a single product to the concept of strategic alliance between partners.

Not only for the development of complete product lines but also for the establishment of joint ventures and manufacturing or distribution agreements among companies all over the world.

Services

Market Access

  • COMPLETE and REAL Market Access: From BC to 1st batch on market
  • Incorporating the local affiliate and the local representative status
  • Local structure and executive search of the team
  • Management and negotiations with logistic operator
  • Implementing the SOPs and WIs, and training of personnel
  • Price and Reimbursement and Value Dossier
  • Company registration in the mandatory databases (MoH, Agency, Social Security Suppliers, etc.…)
  • Tendering tailored service
  • Logistics Operator search and contractual terms
  • Compliance support in promotional materials and events
  • Developing local business case (P & L)

Strategic Market Approach

  • Portfolio analysis for local environment
  • Defining of future pipeline and country market strategy in-licensing/products acquisitions
  • Staff company structure for maximizing the cost/efficiency ratio
  • Price strategy, including commercial policy in retail and Hospitals
  • Business Plan and Projections (P & L, CAPEX, Assets and Liabilities)
  • Promotional Plan, both in prescription and consumer
    healthcare products
  • Customized training plan for sales & marketing forces
  • Due diligence in Mergers and Acquisitions

AREAS OF EXPERTISE

We offer quality solutions to projects of a wide variety of clientele, focusing on different therapeutic areas.

  • Anti infective
  • Cardiovascular
  • Renal
  • CNS
  • Dermatology
  • Endocrinology
  • Gastrointestinal
  • Genitourinary
  • Haematology
  • Immunology
  • Musculoskeletal disorders
  • Oncology
  • Ophthalmology
  • Pain
  • Anaesthesia
  • Geriatrics
  • Paediatrics
  • Advanced Therapies
  • Gene Therapies

QualitecFarma® works with FIH (First in Human), generic drugs, Biotech and Biosimilars, as well as over-the-counter drugs. The drug development process is critical, and we are at the forefront of new advances in research and development incorporating the latest technologies.

We have also played a key role in the establishment of foreign investment in Spain from drug development and clinical support to the registration of medicinal products for companies without presence in the country.

Clinical operations are key to the success of our projects. Our clinical trials conducted in different sites worldwide are evidence of the far-reaching strong partnership between QualitecFarma® and clients. We incorporate all the different phases according to the necessity of the client and the project, emphasising flexibility to accommodate their requirements.

Our support extends to post-marketing pharmacovigilance, ensuring a safety monitoring process, handling regulatory affairs, and assuring quality in our work.

As the world takes a progressive step towards more revolutionary medical technology, we at QualitecFarma® partake in the grand effort to unleash the innovative breakthroughs carried out through the projects we have with our clients.

The process may be complex and strict, but we serve as strategic guides on the path to obtaining a quality final product. Part of that journey includes tasks such as performing analytical and clinical performance studies (the ability of IVD medical devices to detect or measure certain samples, and having those devices successfully realise their purpose as intended). Further services from our experts include dossier creation and submission.

We take part in different qualification projects for the creation and auditing of quality systems, according to ISO 13485, to ensure compliance with the latest
regulations. Our goal is to bring to the market, cutting edge smart solutions that deliver value.

Veterinary medicines have undergone massive developments over these past years. Regulatory affairs and pharmacovigilance have become strong pillars in animal health.

The uses of veterinary medicinal products and their impact on the environment and animals, even on humans, require monitoring.

Though ever-evolving, the legislation aims to reduce the administrative burden and strengthen the scientific background of pharmacovigilance. Our customizable and client-tailored veterinary post-marketing pharmacovigilance services englobe all strides to ensure compliance with legislation and dealing with possible safety issues linked to the benefit/risk balance of every veterinary medicinal product.

Our continued participation in projects for the establishment of synergies and strategic alliances ensures the success and improved development in this area. The regulatory activity in the veterinary field is also a vital support for companies in animal care and therapeutics, along with the guarantee of quality in our work.

We have developed our activity working with companies dealing with food supplements, dietetic products, novel foods, etc. In general, these are products whose use and regulation is gradually more strictly regulated.

Technology moves forward faster than regulations. Their demand applied nowadays to all products for human use make it difficult to launch certain products when their classification is being hampered by the technology applied.

QualitecFarma® provides support to the companies for the registration, authorisation, and notification of placing on the market for products that, without being medicinal products or medical devices, or even cosmetic products, require very strict approaches of registration and approval for granting their authorisation by the Health Authorities.

We evaluate and study the possibilities of development, authorisation, and marketing for the products based on the applicable regulations, determining their legal viability.

Cosmetics are key components of our care, health, and wellness-related activities. However, cosmetics can also arise undesirable and adverse effects which must be monitored. For that reason, today, the safety of cosmetic products must be also controlled under a high-quality post-marketing surveillance.

The Cosmetics Regulation (EC) No. 1223/2009 in the European Union (EU) upholds cosmetovigilance, establishing as its main purpose the management of undesirable effects and safety issues, involving their collection, assessment, monitoring, and understanding of their nature and future prevention.

QualitecFarma® provides support and services to comply with cosmetovigilance legislation. We have a large experience in the development of the safety and value dossier for cosmetics where quality and safety are the definition of a cosmetic product, through scientific evaluations and cosmetovigilance.

QualitecFarma® is open committed to the new health related technologies. We encompass additional areas of expertise including latest up-to-date technologies such as:

  • Life-therapeutic biologics (LTBs)
  • Probiotics
  • Biocides
  • Parapharmaceuticals
  • Nutraceuticals