APCER Life Sciences

GB PHARMA GROUP is an established and innovative pharma consulting services organization, which, operating in a constantly changing environment as the Life Science sector, has grown over the years. By understanding our Clients' commercial needs, we provide services in the field of Clinical Resaerch, Regulatory Affaris, Pharmacovigilance and Market access.

The Group is structured into three Companies:
GB Pharma Services & Consulting was established in 1999, as CONTRACT RESEARCH ORGANIZATION of the Group specialized in clinical research services.
Over the years the business model has evolved thanks to the involvement of sister companies, as GB Pharma srl, specialized in post-marketing development phases, including Regulatory Affairs, Pharmacovigilance and Market access, and 3B Biotech Research S.a.g.l.,
promoter of a ambitious internationalisation project.

The group concept is based therefore on the continuous development of internal know-how, applied by a well connected and multidisciplinary team, with excellent technical and scientific skills, specific to Pharma industry. Our goal is to maximize the value of our Clients' product portfolio.

Thanks to this corporate sinergy, and to more than 20 years of experience gained in the Life Science sector, we are able to provide a 360° support.
We consider ourselves as “Your Best Partner” and offer a business model based on the establishment of strategic partnership and on the provision of high-added value services to support our Clients during the development, research and marketing programs.

Our services include:
• Clinical trials, RWE, Observational and outcome research (medicinal products, medical devices, food supplements and cosmetics);
• Patient Support Program;
• Market Access;
• Medical writing;
• Pharmacovigilance post-marketing;
• Quality System & Compliance
• Regulatory Affairs.

We are an established all-phase contract research organization (CRO) based in Berlin, Germany.

We provide complete turn-key solutions for all stages of the clinical development process, including data management, biostatistics, clinical and medical monitoring as well as medical writing and pharmacovigilance services.

We are involved in several global clinical trials and – through collaboration with strong partners – has established a position at the forefront of the latest developments in the world of clinical research. We can manage complete clinical projects from initial trial inception through to regulatory submission.

Our experienced team has substantial expertise in the various divisions of clinical research which enables the company to offer services from preclinical to phase I-IV and post-marketing studies for pharmaceutical, biotech and medical device companies.

OCT is the leading contract research organization in Russia. Since 2005, OCT’s team has conducted over 300 clinical trials in Eastern Europe and the CIS region. Our team of 150+ clinical professionals provides a full range of high-quality CRO services for Phase I-IV and BE studies, with therapeutic expertise in oncology, infectious disease, and all major therapeutic indications.

As pharmaceutical and biotechnology companies have turned toward outsourcing models in clinical research, OCT has established itself as one of the top contract research organizations worldwide. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration, on time and within budget.

Our experienced team delivers a full range of CRO services:

Clinical Study Design Preparation
Medical Writing
Consulting and Regulatory Support
Project Management and Monitoring
Drug Safety and Pharmacovigilance
Data Management
Biostatistics
Clinical Supply Services and Logistics
Marketing Authorization
GMP Inspection Support

DataClin is a Contract Research Organization (CRO) in Egypt focusing on Clinical data management, Bio-statistics, Medical writing, Clinical monitoring, pharmacovigilance, Consultancy, and training services.

We, at DataClin, work according to a full set of standards covering our scope of work, with an ongoing process of updates as per international, regional, and local regulatory requirements and guidelines with full respect to customer-specific standards.

We commit ourselves to excellence, focusing on people development, and are able to perform clinical research projects, spanning across various therapeutic areas, while delivering high-quality output.

DataClin is able not only to reach our partner expectations; yet exceeding those expectations from all perspectives.

DataClin team aims to grow together with our customers always demanding the highest standard of professionalism and integrity of ourselves with a commitment to consistent quality and execution.

DataClin team has extensive experience that captures the full workflow of Clinical Data Management, Biostatistics and Medical Writing and Clinical Monitoring processes on all phases of clinical trials as well as post-marketing registries.

We have a wide experience in multinational pharmaceutical business having experience with most of the top 10 multinational companies.

Please visit us at www.dataclin.com

Marti Farm Ltd, company based in Zagreb, Croatia is a CONTRACT RESEARCH ORGANIZATION supporting the needs of the pharmaceutical, biotechnology, medical devices, food supplement and cosmetics industries across a variety of core services areas. We are internationally recognized as a reliable partner and provider of consultancy and regulatory services with proven track record of 8+ years. Our core belief is continuous personal development aimed at strengthening our expertise and approaches in order to drive added value for our clients from both the operational and the strategic aspects. Over the last several years, we have been increasingly expanding our business internationally in search for new satisfied clients and trusted partners.

Our core service areas:

SAFETY MONITORING
• Pharmacovigilance
EU QPPV, Local QPPV, operational
Literature screening
PASS
• Pharmacovigilance in clinical trials
• Vigilance
• Cosmetovigilance

REGISTRATION
• Medicinal products and medical devices
• Cosmetic products
• Food supplements
• RUT/PIL & bridging report

CLINICAL TRIALS
• We offer full services for conducting clinical trials with individual approach to each client so we can offer service at every stage of the trial (phases I, II, III and IV).

MEDICAL WRITING
• We offer medical writing services in the field of pharmacovigilance and regulatory affairs.

TRANSLATION
• We provide you with accurate translations made by experienced language experts.

PATIENT SUPPORT PROGRAMS
• We in Marti Farm rise up to the challenge by giving the patients access to the support they need while ensuring healthcare utilization.

AUDITING
• Our certified teams will help you establish a QMS and guide you through audits.

MEDICAL MARKETING
• Our medical marketing team would love to become your partner and guide through the ever-evolving landscape of medical communications and publications.

HEALTH ECONOMICS AND MARKET ACCESS
• HE Analyses
• Pricing, reimbursement & market access