Clinical Operations & Project Management

Clinical Operations have a lot of interaction with people in a range of other departments including Clinical Science, Clinical Quality Assurance, Data Management, Biostatistics and Regulatory Affairs to ensure that the data and information needed by these other departments is delivered so they can decide if a trial has been successful. The Clinical Operations function of a company is key to the delivery of clinical trials. Without this team no Clinical Research activity could be delivered. Clinical Operations teams are responsible for designing, planning and physically running Phase I – IV clinical trials. Many larger pharmaceutical companies have also looked at setting up strategic partnerships with Clinical Research Organizations to outsource some or all of their Clinical Operations activities.

Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.

 

  • Early clinical development: Operational strategies
  • Misconduct and fraud in clinical trials
  • Managing risk with contracts: Informed consent, Subject injury, Insurance & Indemnification
  • Integrating quality into clinical trials
  • Risk-Based monitoring
  • Setting & managing priorities in a clinical project schedule
  • Clinical trial project management platforms
  • Translation of clinical trial documents – challenges, options and solution
  • Streamlining R&D clinical trials operations
  • Transforming clinical development
  • Good clinical practice and inspection readiness

Related Conference of Clinical Operations & Project Management

March 18-19, 2019 |

9th International Conference on Clinical Research & Clinical Trials 2019

Holiday Inn Paris – Porte de clichy, Paris, France
March 20-21, 2019

2nd International Conference and Exhibition on Pharmaceutical Nanotechnology and Nanomedicine

| Hilton New York JFK Airport Hotel | New York, USA
March 25-26, 2019

World Congress on Pharmaceutical Biotechnology & Bioengineering

Orlando, Florida, USA
March 27-28, 2019

5th International Conference on Clinical Pharmacy and
Health Care

San Antonio, Texas, USA
April 04-06, 2019

4th Annual Congress on Nanomedicine and Drug Delivery

Auckland, NewZealand
April 15-16, 2019

12th European Biosimilars Congress

Berlin, Germany
April 17-18, 2019

11th World Congress on Pharmacology & Therapeutics

Montreal, Canada
April 17-18, 2019

Annual Neurochemistry and Neuropharmacology Congress

| Montreal, Canada
April 17-18, 2019

International Conference on Global Analytica

Osaka, Japan

April 22-23, 2019

20th Asia-Pacific Pharma Congress

Tokyo, Japan
April 25-26, 2019 |

14th Annual Meet on Euro Ethnopharmacology

Holiday Inn Amsterdam – Arena Towers | Hoogoorddreef 66a, 1101 BE Amsterdam, Netherlands
May 01-02, 2019 Amsterdam | Netherlands

11th Annual Meet on Molecular Pharmacology 2019

May 06-07, 2019

11th World Congress on Neuropharmacology

Prague, Czech Republic
May 20-22, 2019

21st Annual European Pharma Congress

Zurich, Switzerland
March 22-23, 2019

5th International Conference on Antibiotics

Orlando, USA
June 14-15, 2019 |

13th World Drug Delivery Summit

Montreal, Canada
July 29-30, 2019

7th European Biopharma Congress

Stockholm, Sweden
June 27-28, 2019

4th Pharmaceutical Chemistry Conference

Amsterdam, Netherlands
June 27-28, 2019

18th Annual Congress on Pharmaceutics & Drug Delivery Systems

Amsterdam, Netherlands
June 27-28, 2019

12th World Congress on Future Pharma

Amsterdam, Netherlands
July 15-16, 2019

6th World Congress on Drug Discovery & Toxicology

Abu Dhabi, UAE
July 19-20, 2019

8th International Conference on Clinical Trials

| Atlanta, USA
July 19-20, 2019

8th International Conference on Clinical Trials

| Atlanta, USA

August 02-03, 2019

9th International Conference on Pharmaceutical GMP, GCP & Regulatory Affairs

| Pharmaceutical Research, Education, Expo & Networking | Chicago, USA
August 19-20, 2019

24th World Congress on Pharmacology

Vienna, Austria
September 11-12, 2019

14th World Congress on Pharmacology and Toxicology

Singapore
September 11-12, 2019

World Congress on Drug Discovery and Drug Design

Singapore
September 18-19, 2019

6th World Congress on Natural Products, Medicinal Plants and Traditional Medicines

| Radisson Narita | Tokyo, Japan
October 10-11, 2019

15th World Congress on Medicinal Chemistry & CADD

Dubrovnik | Croatia
October 14-15, 2019

19th World Congress on Advances in Pharmaceutical Sciences

Courtyard Marriott Seoul Times Square | Seoul, South Korea
November 03-04, 2019

Advanced Pharmaceutics and Clinical Research

| Paris, France
September 11-12, 2019

2nd Annual Pharmaceutical Biotechnology Congress

Singapore
November 11-12, 2019

20th Annual Pharma Middle East Congress

Istanbul, Turkey
November 14-15, 2019

2nd World Congress on Bioorganic and Medicinal Chemistry

Cape Town, South Africa
November 18-19, 2019

27th Global Experts Meeting on Neuropharmacology

Rome, Italy
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14th World Congress on Pharmacology and Drug Safety

Nice, France

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