Rapid
Response

 

Drug Development Services

Clinical trial delays can turn a potentially successful medication into an unfortunate financial loss if not timely developed and marketed. Minimal drug awareness and clinical exposure of Investigators will likely affect the drug future success.

Key success factors:

  • Create and implement a drug development program that answers a simple medical question and rapidly provide an answer in an area of high medical need.
  • Avoid clinical trial delays. The choice of a Contract Research Organization (CR0) unfamiliar with the oncology therapeutic area, may turn a potentially successful drug into an expensive financial loss.
  • Long-term relationship with the investigating sites ensures investigator sites patient enrollment to be rapid, delivered with high quality data and on time.
  • Extensive investigators clinical experience through participation to core trials but without neglecting the importance of Investigators led studies

 

 

Services Advantage

  • Full access to worldwide Key opinion leaders to advise and support the drug development design program meeting current and future medical needs in oncology

  • Our extensive ties to leading international experts regrouping a network of over 500 oncologists from around the world to ensure that target patient enrollment and clinical trial data is obtained rapidly. (Canada, the U.S., Europe, South America, and Australia) despite other competing studies

  • Enables your clinical program to quickly gain high exposure, awareness and visibility on a National or if required International basis.

  • Allows you to collect data rapidly with high patient accrual, providing essential data to complete the studies necessary for drug registration and marketing.

  • Collected data is of the highest quality, fulfilling Health Authority requirements ensuring easier drug registration flow and allowing for a quick drug marketing.

  • Extensive experience in directing over 125 local and international multi-centre Clinical Trials (Phase I-IV) in Canada, in tandem with the USA and the European Community.

  • Extensive experience in managing clinical trials in over 450 research sites, with combined budgets of over $35 million

  • Extensive clinical trial work resulting in the introduction of 6 new products in oncology onto the market.

  • Extensive experience in managing several Investigators led studies at the same time( >10)

Extensive experience in writing and submitting several abstracts and publications in Medical peer reviewed Journals

 

 

Services Expertise

  • Developing Medical Strategic Plans
  • Organizing Medical Advisory Boards with Worldwide Leading Experts
  • Clinical Trial Research / Management (Phase I to Phase IV trials)
  • Development of protocol and case report forms (CRFs) design, either with or without an accompanying economic study
  • Pre-IND meetings with Health Authorities
  • Site recruitment,
  • Organizing and conducting investigator meetings
  • Obtaining approvals from local ethics committees and all relevant documentation pertinent to studies
  • Site visits and study initiation
  • Monitoring single institution or multi-center studies
  • Collecting and analyzing blood samples through a central laboratory
  • Managing study's biological samples transport and analysis
  • Data & site management
  • Reporting of serious adverse events (SAEs)
  • Data analysis.
  • Writing narrative, integrated trial reports, overall summaries, abstracts and manuscripts for publications.
  • Negotiating with independent bodies such as the National Cancer Institute of Canada (NCIC) to plan drug development (concept) and trials implementation for new oncology drugs or indications for Phase I-III
  • Supporting your clinical team in areas of difficulty in obtaining participating strategic clinical research sites on board
  • Writing standard Operating Procedures (SOP s) in line with Good Clinical Research Practices and new ICH guidelines
  • Health economic evaluations of drug products or health services
  • Statistical analysis of large drug utilization databases
  • Meta-analysis of clinical trials using fixed or random effects models
  • Questionnaire development and administration for survey-type research
  • Clinical guideline development and implementation
  • Medical writing on events during Symposium
  • Promotional material Review Approval
  • Scientific Literature Review
  • Translation of scientific material (English-French-English)

 

Services Success

Abugaber Canada, Oncology Management Services Team Members has a proven track record of:

  • Ensuring many successful drug developments in several indications in the field of oncology.
  • Obtained earlier regulatory approval for IND
  • Obtained earlier regulatory drug approval.
  • Obtained faster market access.
  • Obtained earlier financial return on the investment.

 

Abugaber Canada, Oncology Management Services provides a personal service tailored to your needs. Whatever your requirements may be, they will be met by an expert who specializes in that field.

Abugaber Canada, Oncology Management Services, with a dedicated, professional staff and proven track record in oncology drug development, will ensure your product full integrated development and completion to a high quality standard for registration is brought to the market, on time.

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