1 EXHIBIT 5.01 SMITH, ANDERSON, BLOUNT, DORSETT, MITCHELL & JERNIGAN, L.L.P. OFFICES MAILING ADDRESS 2500 FIRST UNION CAPITOL CENTER P.O. BOX 2611 RALEIGH, NORTH CAROLINA 27601 RALEIGH, NORTH CAROLINA 27602-2611 February 17, 1999 TELEPHONE: (919) 821-1220 FACSIMILE: (919) 821-6800 Quintiles Transnational Corp. 4709 Creekstone Drive Riverbirch Building, Suite 200 Durham, North Carolina 27703-8411 RE: REGISTRATION STATEMENT ON FORM S-4 Ladies and Gentlemen: We are counsel for Quintiles Transnational Corp. (the "Company") in connection with the issuance by the Company of up to 30,717,729 shares of the Company's Common Stock, $0.01 par value per share to be issued in exchange for the shares of Common Stock and Series B Convertible Preferred Stock of ENVOY Corporation ("ENVOY") outstanding as of the effective date of the merger of QELS Corp., a Tennessee corporation which has not engaged in any material operations since its incorporation and is a wholly owned subsidiary of the Company, with and into ENVOY (the "Merger"). These shares are described in the Company's Registration Statement on Form S-4 to be filed with the Securities and Exchange Commission (the "Commission") under the Securities Act of 1933, as amended (the "Act"), on February 17, 1999, with which this opinion will be filed as an exhibit (the "Registration Statement"). This opinion is furnished pursuant to the requirement of Item 601(b)(5) of Regulation S-K under the Act. We have examined the Amended and Restated Articles of Incorporation, as amended, and the Amended and Restated Bylaws of the Company, the minutes of the meetings of the Board of Directors of the Company relating to the authorization and the issuance of securities and such other documents, records, and matters of law as we have deemed necessary for purposes of this opinion. In our examination, we have assumed the genuineness of all signatures, the authenticity of all documents as originals, the conformity to originals of all documents submitted to us as certified copies or photocopies, and the authenticity of the originals of such latter documents. In rendering the opinion set forth below, we have relied on a certificate of a Company officer, whom we believe is responsible. Based upon the foregoing and the additional qualifications set forth below, it is our opinion, as of the date hereof, that the 30,717,729 shares of Common Stock of the Company which are being registered pursuant to the Registration Statement are duly authorized and, when 2 February 17, 1999 Page 2 issued and delivered in exchange for the shares of ENVOY Common Stock and Series B Convertible Preferred Stock surrendered in the Merger, as contemplated by the Registration Statement, such shares will be validly issued, fully paid and nonassessable. The opinion expressed herein does not extend to compliance with state and federal securities laws relating to the sale of these securities. We hereby consent to the reference to our firm under the heading "Legal Matters" in the Registration Statement and to the filing of this opinion as an exhibit to the Registration Statement. Such consent shall not be deemed to be an admission that this firm is within the category of persons whose consent is required under Section 7 of the Act, or the regulations promulgated by the Commission pursuant to such Act. This opinion is limited to the laws of the State of North Carolina, and no opinion is expressed as to the laws of any other jurisdiction. Our opinion is as of the date hereof, and we do not undertake to advise you of matters that might come to our attention subsequent to the date hereof which may affect our legal opinion expressed herein. Sincerely yours, /s/ SMITH, ANDERSON, BLOUNT, DORSETT, MITCHELL & JERNIGAN, L.L.P.